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GOVERNMENT OF THE RUSSIAN FEDERATION RESOLUTION of April 3, 2020 N 430 List of changing documents amended
来源: | 作者:上海卡卢加 | 发布时间: 2022-01-12 | 38 次浏览 | 分享到:
GOVERNMENT OF THE RUSSIAN FEDERATION RESOLUTION of April 3, 2020 N 430 List of changing documents amended
ABOUT FEATURES HANDLING OF MEDICAL DEVICES, INCLUDING STAT REGISTRATION OF A SERIES (LOTS) OF A MEDICAL DEVICE
List of changing documents(as amended by Resolutions of the Government of the Russian Federation dated 02.06.2020 N 804

GOVERNMENT OF THE RUSSIAN FEDERATION

 

RESOLUTION

of April 3, 2020 N 430

 

ABOUT FEATURES

HANDLING OF MEDICAL DEVICES, INCLUDING STATE

REGISTRATION OF A SERIES (LOTS) OF A MEDICAL DEVICE

 

List of changing documents

(as amended by Resolutions of the Government of the Russian Federation dated 02.06.2020 N 804,

from 13.11.2020 N 1826, from 06.03.2021 N 337, from 10.12.2021 N 2250,

from 28.12.2021 N 2506)

 

In accordance with Part 5.1 of Article 38 of the Federal Law "On the Basics of Health Protection of Citizens in the Russian Federation" and Clause 2 of Part 1 of Article 17 of the Federal Law "On Amendments to Certain Legislative Acts of the Russian Federation on the Prevention and Elimination of Emergencies", the Government of the Russian Federation decides :

1. To approve the attached features of the circulation of medical devices, including the state registration of a series (batch) of a medical device.

2. This resolution comes into force from the date of its official publication and is valid until January 1, 2025.

(as amended by the Resolutions of the Government of the Russian Federation of 13.11.2020 N 1826, of 10.12.2021 N 2250)

 

Prime Minister

Russian Federation

  1. MISHUSTIN

     

     

     

     

     

     

     

     

     

     

    Approved

    government decree

    Russian Federation

    of April 3, 2020 N 430

     

    PECULIARITIES

    HANDLING OF MEDICAL DEVICES, INCLUDING STATE

    REGISTRATION OF A SERIES (LOTS) OF A MEDICAL DEVICE

     

    1. This document applies to the circulation of medical devices that are intended for use in military operations, emergency situations, emergency prevention, prevention and treatment of diseases that pose a danger to others, diseases and injuries resulting from exposure to adverse chemical, biological, radiation factors, according to the list according to Appendix No. 1 (hereinafter - the medical device), including the state registration of a series (batch) of a medical device.

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    ConsultantPlus: note.

    Registration certificates for a series (batch) of a medical device according to the list according to Appendix 1, issued before 12/22/2021, are valid until 01/01/2025 without replacing the registration certificate (Decree of the Government of the Russian Federation of 12/10/2021 N 2250).

     

    2. A registration certificate for a series (batch) of a medical device is issued with a validity period until January 1, 2025.

    (as amended by the Resolutions of the Government of the Russian Federation of 13.11.2020 N 1826, of 10.12.2021 N 2250)

    3. For state registration of a medical device, a developer, manufacturer (manufacturer) of a medical device, an authorized representative of a manufacturer (manufacturer) or a person importing a medical device into the Russian Federation for the purpose of its state registration (hereinafter referred to as the applicant) shall submit or send to the federal state budget institutions under the jurisdiction of the Federal Service for Surveillance in Healthcare (hereinafter referred to as the expert institution), in the form of an electronic document and (or) on paper:

    an application for state registration of a medical device in accordance with the requirements of paragraph 9 of the Rules for state registration of medical devices, approved by the Government of the Russian Federation dated December 27, 2012 N 1416 "On approval of the Rules for state registration of medical devices" (hereinafter - the Registration Rules);

     

    a copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer) (if any);

    documents confirming the belonging of the series (batch) of the medical device to the applicant on legal grounds;

    manufacturer's (manufacturer's) technical documentation for a medical device (if any);

    manufacturer's (manufacturer's) operational documentation for a medical device that meets the requirements approved by the Ministry of Health of the Russian Federation;

    photographic images of a general view of a medical device together with accessories necessary for the intended use of the medical device (at least 18 by 24 centimeters in size);

    documents confirming the results of technical tests of a medical device, toxicological studies of a medical device, the use of which involves contact with the human body, clinical trials of a medical device conducted in accordance with a standard test program depending on the type of medical device developed by an expert institution (hereinafter referred to as a standard program ), and published on the official websites of expert institutions in the information and telecommunications network "Internet" (as applicable). If tests (studies) are carried out in the Russian Federation according to a program different from the standard one, the expert institution determines the sufficiency of such studies (tests) for the purposes of state registration of a series (batch) of medical devices in accordance with this document;

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    other documents characterizing the quality, effectiveness and safety of a medical device (if any);

    list of documents.

     

    If these documents are drawn up in a foreign language, they are submitted with a translation into Russian certified by the applicant.

    The requirements established by the Ministry of Health of the Russian Federation on the conformity assessment of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices are not mandatory for testing (research) of medical devices included in the list. This provision shall apply until the elimination of the threat of an emergency or the elimination of an emergency. Medical devices that have not passed the specified conformity assessment are subject to re-registration in accordance with the legislation of the Russian Federation.

    4. The expert institution, within 3 working days from the date of receipt of the documents specified in paragraph 3 of this document, assesses their completeness, sufficiency and completeness, including the sufficiency of the volume of tests (studies) of medical devices for the purposes of state registration of a batch (batch) medical devices in accordance with this document, draws up an opinion on the possibility (impossibility) of state registration of a series (batch) of medical devices in the form established by the Ministry of Health of the Russian Federation for the purpose of examining the quality, effectiveness and safety of a medical device, and sends it to the Federal Service for Supervision in the field of health care.

    The documents submitted by the applicant in accordance with paragraph 3 of this document are attached to the conclusion of the expert institution.

    If the materials and information contained in the documents provided by the applicant provided for in paragraph 3 of this document are insufficient for the expert institution to issue an opinion, the expert institution, within 2 working days from the date of receipt of these documents, sends to the applicant by registered mail with a receipt acknowledgment or in the form of an electronic document , signed with an electronic signature, or in electronic form via telecommunication channels, a request for the submission of the necessary information, indicating the nature of the comments and the way to eliminate them (hereinafter - the request).

    (the paragraph was introduced by the Decree of the Government of the Russian Federation of 06/02/2020 N 804)

    The applicant is obliged to submit a response to the request of the expert institution within a period not exceeding 5 working days from the date of receipt of the request. The expert institution prepares an opinion within 2 working days from the date of receipt of a response to the request from the applicant.

    (the paragraph was introduced by the Decree of the Government of the Russian Federation of 06/02/2020 N 804)

     

    If the applicant fails to provide a response to the request after 5 working days, the expert institution prepares an opinion on the basis of the documents at its disposal.

    (the paragraph was introduced by the Decree of the Government of the Russian Federation of 06/02/2020 N 804)

    5. A conclusion on the impossibility of state registration of a series (batch) of medical devices is drawn up by an expert institution if there are the following grounds (one or more):

    a) there is no evidence of the compliance of the medical device with the requirements of the manufacturer's (manufacturer's) documentation;

    b) there is no evidence of the safety of the medical device;

    c) the quality, and (or) effectiveness, and (or) safety of the medical device is not confirmed by the received data;

    d) the risk of harm to the health of citizens and medical workers due to the use of a medical device exceeds the effectiveness of its use;

    e) the medical device is absent from the list provided for by Appendix No. 1 to this document;

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    f) the documents specified in clause 3 of this document are not presented in full.

     

    6. Federal Service for Surveillance in Healthcare within 2 working days from the date of receipt of the opinion specified in paragraph 4 of these features:

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    a) makes a decision on state registration of a series (batch) of a medical device, formalized by an order of the Federal Service for Surveillance in Healthcare, sends the applicant a registration certificate for a medical device by registered mail with a receipt acknowledgment or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels, enters into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, information about the registered series (batch) of medical products);

    b) makes a decision to refuse state registration of a series (batch) of a medical device and sends a reasoned refusal to the applicant by registered mail with a receipt acknowledgment or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels (in case of receipt of an opinion on the impossibility of state registration of a medical device).

    7. A registration certificate for a series (batch) of a medical device is drawn up in accordance with the requirements of clause 56 of the Registration Rules with an additional indication of its validity period, a series (batch) number of a medical device, serial numbers of medical devices (if any).

    7 (1). With regard to the medical devices specified in paragraphs 1 - 18 of Appendix No. 1 to this document, it is allowed to make changes to the name of the medical device in terms of changing the information about its serial number (if any), the series (batch) number, if others have not changed. information contained in the documents of the registration dossier.

    (Clause 7 (1) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    7 (2). To make the changes specified in clause 7 (1) of this document to the documents contained in the registration dossier, the applicant submits (sends) to the Federal Service for Surveillance in Healthcare:

    an application for amending the documents contained in the registration dossier (hereinafter referred to as an application for amending), drawn up in accordance with clause 9 of the Registration Rules;

    a copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer) (if any);

    documents confirming the belonging of the series (batch) of the medical device to the applicant on legal grounds;

    photographic images of a general view of a medical device together with accessories necessary for the intended use of the medical device (at least 18 by 24 centimeters in size);

    manufacturer's document confirming that the medical device with the declared serial numbers (if any), batch (batch) numbers is identical to the medical device originally registered in accordance with this document;

    original registration certificate;

    list of documents.

    If these documents are drawn up in a foreign language, they are submitted with a translation into Russian certified by the applicant.

    (Clause 7 (2) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

     

    7 (3). The application for amendments and the documents provided for in clause 7 (2) of this document shall be submitted by the applicant to the Federal Service for Surveillance in Healthcare in hard copy directly or sent by registered mail with a return receipt and a list of attachments or in the form of an electronic document.

    The Federal Service for Surveillance in Healthcare accepts the application for amendments and the documents provided for in paragraph 7 (2) of this document, according to the inventory.

    (Clause 7 (3) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    7 (4). Within 3 working days from the date of receipt of the application for amendments and documents provided for in paragraph 7 (2) of this document, the Federal Service for Surveillance in Healthcare checks the completeness and reliability of the information contained therein and carries out:

    a) making a decision on amending the documents contained in the registration dossier, which is drawn up by order of the Federal Service for Surveillance in Healthcare, entering into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, relevant information or decisions on the return of the application for amendments and the documents provided for in paragraph 7 (2) of this document, with a reasoned justification of the reasons for the return;

    b) notification in writing of the applicant of the decision taken by registered mail with a receipt acknowledgment with the attachment of the reissued registration certificate (if changes are made to it) and the previously issued registration certificate with a mark of its invalidity (indicating the date).

    (Clause 7 (4) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    8. The Federal Service for Surveillance in Healthcare forms a registration dossier for a series (batch) of a medical device using the following documents:

    a) an application for state registration and documents provided for in paragraph 3 of this document, as well as an application for amendments and documents provided for in paragraph 7 (2) of this document;

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    b) conclusion on the possibility (impossibility) of state registration of a series (batch) of a medical device;

    c) a decision on state registration of a series (batch) of a medical device, drawn up by an order of the Federal Service for Surveillance in Healthcare;

    d) a copy of the registration certificate and copies of notifications issued by the Federal Service for Surveillance in Healthcare.

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    9. The state duty for the issuance of a registration certificate is paid in accordance with the legislation of the Russian Federation on taxes and fees.

    10. It is allowed to import into the Russian Federation without obtaining permission from the Federal Service for Surveillance in Healthcare of unregistered medical devices according to the list provided for in Appendix No. 1 to this document, in the amount necessary for testing (research), state registration and subsequent sale. This provision is valid until the elimination of the threat of an emergency and (or) the elimination of the emergency.

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    It is allowed to import into the Russian Federation, sale, transportation, storage, use and disposal (destruction) of disposable medical devices not registered in the Russian Federation according to the list provided for in Appendix No. 1 to this document, without obtaining permission from the Federal Service for Surveillance in Healthcare, if the specified products are registered in the established order in the country of origin.

    (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    The applicant is obliged, within 3 working days from the date of importation of unregistered medical devices into the Russian Federation, through the automated information system of the Federal Service for Supervision in Healthcare, information on the series (lots) of medical devices in accordance with Appendix No. 2 to this document.

    (as amended by the Resolutions of the Government of the Russian Federation of 06/02/2020 N 804, of 03/06/2021 N 337)

    Reusable medical devices imported into the Russian Federation that are not registered in accordance with this document, after January 1, 2025, are subject to destruction or removal from the territory of the Russian Federation.

    (as amended by the Resolutions of the Government of the Russian Federation of 13.11.2020 N 1826, of 10.12.2021 N 2250)

    The applicant weekly, until January 1, 2025, in respect of unregistered and registered in accordance with this document and with the Rules for the registration of medical devices specified in clauses 19 - 78 of Appendix No. health care information in accordance with Appendix No. 2 to this document on their implementation, on export from the territory of the Russian Federation or on destruction in accordance with this document.

    (as amended by Resolutions of the Government

     

  1. The Federal Service for Surveillance in Healthcare makes a decision to cancel the state registration of a series (batch) of a medical device in accordance with subparagraphs "a" - "e" of clause 57 of the Registration Rules.

     

    Appendix N 1

    to the peculiarities of the appeal

    medical devices, including

    state registration of the series

    (batch) of a medical device

     

    SCROLL

    MEDICAL DEVICES THAT ARE INTENDED FOR USE

    IN THE CONDITIONS OF MILITARY ACTIONS, EMERGENCIES, PREVENTION OF EMERGENCIES, PREVENTION AND TREATMENT OF DISEASES PRESENTING A DANGER

    FOR ENVIRONMENTAL DISEASES AND INJURIES RESULTING FROM EXPOSURE TO ADVERSE CHEMICAL, BIOLOGICAL, RADIATION FACTORS

     

    List of changing documents

    (as amended by Resolutions of the Government of the Russian Federation of 10.12.2021 N 2250,

    from 28.12.2021 N 2506)

     

    Type Name

     

    1.169180 Stationary high-frequency artificial lung ventilation apparatus with electric drive

     

    2.275750 Anesthetic artificial lung ventilation apparatus

     

    3.311390 Portable pneumatic high-frequency ventilator

     

    4.314860 High-frequency pneumatic ventilator for patient transportation

     

    5.232870 Neonatal intensive care ventilator / adult

     

    6.232880 Neonatal intensive care ventilator

     

    7.232890 General Purpose Intensive Care Ventilator

     

    8.216540 Automatic pneumatic ventilator, reusable

     

    9.216260 Disposable pneumatic pneumatic ventilator <*>

     

    10.114040 Portable pneumatic ventilator

     

    11.113890 Portable electric ventilator

     

    121180 Manual ventilator, reusable

     

    13.121270 Manual ventilator, single use <*>

     

    14.287620 Negative pressure ventilator

     

    15.318710 Continuous positive pressure ventilator for home use

     

    16.326140 Continuous positive pressure ventilator for newborns

     

    17.274590 Motorized ventilator for patient transport

     

    18.314540 Stationary high-frequency ventilator with pneumatic drive

     

    19.142280 SARS Coronavirus antigens IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    20.142010 SARS Coronavirus antigens IVD, kit, immunochromatographic analysis, express analysis

     

    21.142250 SARS Coronavirus antibodies immunoglobulin A (IgA) / IgG / IgM IVD, kit, immunochromatographic analysis, express analysis

     

    22.142260 SARS Coronavirus immunoglobulin G (IgG) class antibodies IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    23.142300 SARS Coronavirus antibodies of the immunoglobulin G (IgG) class IVD, kit, immunofluorescence analysis

     

    24.142100 SARS Coronavirus antibodies of the immunoglobulin G (IgG) / IgM class IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    25.142120 SARS Coronavirus immunoglobulin G (IgG) / IgM class antibodies IVD, kit, immunofluorescence analysis

     

    26.142130 SARS Coronavirus immunoglobulin M (IgM) class antibodies IVD, kit, enzyme-linked immunosorbent assay  

     

    27.142150 SARS Coronavirus immunoglobulin M (IgM) class antibodies IVD, kit, immunofluorescence analysis

     

    28.142160 SARS Coronavirus nucleic acid IVD, kit, nucleic acid analysis

     

    29.367800 SARS Coronavirus 1 antibodies immunoglobulin A (IgA) / IgG / IgM IVD set, immunochromatographic analysis, express analysis

     

    30.369620 SARS Coronavirus 1 antibodies of class immunoglobulin G (IgG) / IgM IVD, kit, immunofluorescence analysis

     

    31.368770 SARS Coronavirus 1/2 (SARS-CoV-l / SARS-CoV-2) IVD antigens, kit, immunochromatographic analysis, express analysis

     

    32.374590 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, kit, immunochemiluminescent analysis

     

    33.355940 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, kit, enzyme-linked immunosorbent assay (ELISA)

     

    34.355910 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, kit, immunofluorescence analysis, express analysis

     

    35.355920 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, kit, immunofluorescence analysis

     

    36.370090 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, kit, immunochromatographic analysis, express analysis

     

    37.377880 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, kit, immunochromatographic analysis, self-control

     

    38.376420 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, kit, magnetic immunoassay

     

    39.372850 SARS Coronavirus 2 (SARS-CoV-2) IgA / IgG / IgM antibodies IVD, kit, immunochromatographic analysis, express analysis

     

    40.373770 SARS Coronavirus 2 (SARS-CoV-2) antibodies immunoglobulin A (IgA) IVD, kit, immunochromatographic analysis, express

     

    41.373780 SARS Coronavirus 2 (SARS-CoV-2) antibodies immunoglobulin A (IgAyigG IVD, kit, immunochromatographic analysis, express

     

    42.355890 SARS Coronavirus 2 (SARS-CoV-2) antibodies immunoglobulin G (IgG) IVD, kit, immunochromatographic analysis, express

     

    43.356840 SARS Coronavirus 2 (SARS-CoV-2) antibodies immunoglobulin G (IgG) / IgM IVD, kit, immunofluorescence analysis, express

     

    44.355880 SARS Coronavirus 2 (SARS-CoV-2) antibodies immunoglobulin M (IgM) IVD, kit, immunochromatographic analysis, express

     

    45.355870 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin A class antibodies (IgAyigG / IgM IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    46.355900 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin A (IgA) antibodies IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    47.356850 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin A (IgA) / igM antibodies IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    48.373130 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin A (IgA) antibodies IVD, kit, immunochemiluminescence analysis

     

    49.355930 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) / IgM class antibodies IVD, kit, immunofluorescence analysis

     

    50.355950 SARS Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin G (IgG) class IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    51.368680 SARS Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin G (IgG) / IgM class IVD, kit, analysis on biochips

     

    52.370100 SARS Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin G (IgG) class IVD, kit, immunofluorescence analysis

     

    53.356860 SARS Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin M (IgM) class IVD, kit, immunofluorescence analysis

     

    54.376590 SARS Coronavirus 2 (SARS-CoV-2) neutralizing antibodies IVD, kit, immunochromatographic analysis, express

     

    55.376950 SARS Coronavirus 2 (SARS-CoV-2) neutralizing antibodies IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    56.377370 SARS Coronavirus 2 (SARS-CoV-2) neutralizing antibodies IVD, kit, immunochromatographic analysis, self-control

     

    57.355960 SARS Coronavirus 2 (SARS-CoV-2) general antibodies IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    58.356820 SARS Coronavirus 2 (SARS-CoV-2) general antibodies IVD, kit, immunochemiluminescence assay

     

    59.369630 SARS Coronavirus 2 (SARS-CoV-2) general antibodies IVD, kit, magnetic immunoassay

     

    60.377140 SARS Coronavirus 2 (SARS-CoV-2) general antibodies IVD, kit, magnetic immunoassay, express

     

    61.377360 SARS Coronavirus 2 (SARS-CoV-2) general / neutralizing antibodies IVD, kit, immunochromatographic analysis, self-control

     

    62.378010 SARS Coronavirus 2 (SARS-CoV-2) general / neutralizing antibodies IVD, kit, immunochromatographic analysis, express

     

    63.378840 SARS Coronavirus 2 antibodies of the class immunoglobulin A (IgA) / IgM IVD, kit, immunochemiluminescence analysis

     

    64.356750 SARS Coronavirus 2 antibodies of class immunoglobulin G (IgG) IVD, kit, immunochemiluminescence analysis

     

    65.356740 SARS Coronavirus 2 antibodies of class immunoglobulin M (IgM) IVD, kit, immunochemiluminescence analysis

     

    66.356760 SARS Coronavirus 2 immunoglobulin G (IgG) / IgM antibodies IVD, kit, immunochromatographic analysis, express analysis

     

    67.378200 SARS Coronavirus 2 neutralizing antibodies IVD, kit, nephelometric / turbidimetric analysis

     

    68.375090 SARS Coronavirus 2 neutralizing antibodies IVD, kit, immunofluorescence analysis, express analysis

     

    69.375160 SARS Coronavirus 2 neutralizing antibodies IVD, kit, immunochemiluminescence assay

     

    70.375860 SARS Coronavirus 2 general antibodies IVD, kit, immunochromatographic analysis, express analysis

     

    71.375010 SARS Coronavirus 2 / Influenza virus A / B antigens IVD, kit, immunochromatographic analysis, express analysis

     

    72.375330 SARS Coronavirus 2 / Influenza A / B virus nucleic acid IVD, kit, nucleic acid analysis

     

    73.355970 Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin M class (IgM) IVD, kit, enzyme-linked immunosorbent assay (ELISA)

     

    74.379290 SARS-CoV-2 antigen IVD, kit, electrometric analysis, express analysis

     

    75.368850 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin A (IgA) / IgG / IgM antibodies IVD, set, agglutination test

     

    76.370110 SARS Coronavirus 2 nucleic acid IVD, kit, nucleic acid analysis

     

    77.379360 SARS-CoV-2 antibodies of the immunoglobulin G (IgG) class IVD, kit, immunochromatographic analysis, self-control

     

    78.379590 SARS-CoV-2 immunoglobulin G (IgG) / igM / neutralizing antibodies IVD, kit, immunochromatographic analysis, express

     

    79.369510 SARS Coronavirus 1 IVD antigens, reagent

     

    80.367760 SARS Coronavirus 1 antibodies of class immunoglobulin G (IgG) IVD, reagent

     

    81.369240 SARS Coronavirus 1 antibodies of class immunoglobulin G (IgG) / igM IVD, reagent

     

    82.369880 SARS Coronavirus 1 antibodies of class immunoglobulin G (IgG) / IgM IVD, calibrator

     

    83.369580 SARS Coronavirus 1 antibodies of class immunoglobulin M (IgM) IVD, calibrator

     

    84.369600 SARS Coronavirus 1 antibodies of class immunoglobulin M (IgM) IVD, control material

     

    85.367750 SARS Coronavirus 1 antibodies of class immunoglobulin M (IgM) IVD, reagent

     

    86.369230 SARS Coronavirus 1 antibodies of classes immunoglobulin A (IgA) / IgG / IgM IVD, calibrator

     

    87.369570 SARS Coronavirus 1 antibodies of classes immunoglobulin A (IgA) / IgG / IgM IVD, control material

     

    88.369220 SARS Coronavirus 1 antibodies of classes immunoglobulin A (IgA) / IgG / IgM IVD, reagent

     

    89.369590 SARS Coronavirus 1 nucleic acid IVD, calibrator

     

    90.369610 SARS Coronavirus 1 nucleic acid IVD, reagent

     

    91.374580 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, reagent

     

    92.374540 SARS Coronavirus 2 (SARS-CoV-2) antigen indicator foaming reagent IVD

     

    93.374570 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, calibrator

     

    94.356780 SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, control material

     

    95.

     373810

     SARS Coronavirus 2 (SARS-CoV-2) IVD antigens, control material

     

    96.356830 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) antibodies IVD, calibrator

     

    97.370080 SARS Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin G (IgG) class IVD, control material

     

    98.372580 SARS Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin G (IgG) / IgM class IVD, control material

     

    99.372230 SARS Coronavirus 2 (SARS-CoV-2) immunoglobulin M (IgM) antibodies IVD, calibrator

     

    100.372640 SARS Coronavirus 2 (SARS-CoV-2) antibodies of the immunoglobulin M (IgM) class IVD, control material

     

    101.356810 SARS Coronavirus 2 (SARS-CoV-2) general antibodies IVD, calibrator

     

    102.356790 SARS Coronavirus 2 (SARS-CoV-2) general antibodies IVD, control material

     

    103.356800 SARS Coronavirus 2 (SARS-CoV-2) general antibodies IVD, reagent

     

    104.356770 SARS Coronavirus 2 nucleic acid IVD, control material

     

    105.142050 SARS Coronavirus antigens IVD, calibrator

     

    106.142080 SARS Coronavirus antigens IVD, control material

     

    107.142110 SARS Coronavirus antigens IVD, reagent

     

    108.142030 SARS Coronavirus immunoglobulin G (IgG) antibodies IVD, calibrator

     

    109.142070 SARS Coronavirus antibodies of the immunoglobulin G (IgG) class IVD, control material

     

    110.142090 SARS Coronavirus immunoglobulin G (IgG) class antibodies IVD, reagent

     

    111.142140 SARS Coronavirus immunoglobulin G (IgG) / IgM class antibodies IVD, calibrator

     

    112.142170 SARS Coronavirus antibodies of the immunoglobulin G (IgG) / IgM class IVD, control material

     

    113.142200 SARS Coronavirus immunoglobulin G (IgG) / IgM class antibodies IVD, reagent

     

    114.142180 SARS Coronavirus immunoglobulin M (IgM) class antibodies IVD, calibrator

     

    115.142210 SARS Coronavirus antibodies of class immunoglobulin M (IgM) IVD, control material

     

    116.142230 SARS Coronavirus immunoglobulin M (IgM) class antibodies IVD, reagent

     

    117.142020 SARS Coronavirus antibodies of classes immunoglobulin A (IgA) / IgG / IgM IVD, control material

     

    118.142060 SARS Coronavirus antibodies of classes immunoglobulin A (IgA) / IgG / IgM IVD, reagent

     

    119.142290 SARS Coronavirus antibodies of classes immunoglobulin A (IgA) / igG / IgM IVD, calibrator

     

    120.142190 SARS Coronavirus nucleic acid IVD, calibrator

     

    121.142220 SARS Coronavirus nucleic acid IVD, control material

     

    122.142240 SARS Coronavirus nucleic acid IVD, reagent

     

    123.191440 Adapter for the introduction of cardioplegic solution <*>

     

    124.207560 Adapter for inhalation therapy, reusable

     

    125.216020 Nucleic acid amplifier thermocyclic (thermocycler) IVD, laboratory, semi-automatic

     

    126.215980 Nucleic acid amplifier thermocyclic (thermocycler) IVD, laboratory, automatic

     

    127.347450 m thermocyclic nucleic acid polyester (thermocycler) IVD, for use near a patient

     

    128.216000 Thermal cycling nucleic acid amplifier (thermal cycler) IVD, manual

     

    129.186000 Automatic immunochemiluminescent analyzer for IVD

     

    130.114060 Analyzer immunological photometric IVD, battery powered

     

    131.325350 Immunofluorescence / spectrophotometric IVD analyzer, for use near a patient

     

    132.113940 Analyzer immunofluorescence IVD, for use near a patient, power supply

     

    133.113990 Analyzer immunofluorescence IVD, for use near a patient, battery power

     

    134.261440 Analyzer immunofluorescence IVD, laboratory, automatic

     

    135.218430 Telemetry blood pressure measuring device

     

    136.216560 An electronic device for measuring blood pressure, automatic, portable, with a finger cuff

     

    137.216630 An electronic device for measuring blood pressure, automatic, portable, with a cuff on the shoulder / wrist

     

    138.216350 Electronic device for measuring blood pressure with automatic inflation of air, stationary

     

    139.261820 General purpose applicator / swab with absorbent tip, single use <*>

     

    140.261300 Laboratory water bath with shaking

     

    141. 269290 Waterproof shoe covers <*>

     

    142.141650 Non-conductive shoe covers, non-sterile <*>

     

    143.293810 Shoe covers conductive, non-sterile <*>

     

    144.228180 Boxing laminar

     

    145.143930 Rigid bronchoscope

     

    146.179100 Fiber optic flexible bronchoscope

     

    147.335550 Tray for multichannel pipettes

     

    148.179300 Flexible video bronchoscope, reusable

     

    149.324350 Flexible video bronchoscope, single use <*>

     

    150.207000 Viral transport medium of IVD

     

    151.185630 Water collector for artificial lung ventilation apparatus, reusable

     

    152.185620 Moisture collector of a ventilator, disposable <*>

     

    153.254280 Nasopharyngeal air duct, reusable

     

    154.254300 Nasopharyngeal airway, single use <*>

     

    155.172720 Oropharyngeal air duct, reusable

     

    156.172730 Oropharyngeal air duct, single use <*>

     

    157.254120 Airway with esophageal obturator, reusable

     

    158.254170 Air duct with esophageal obturator, single use <*>

     

    159.254240 Tracheal air duct with esophageal obturator, reusable

     

    160.254040 Tracheal air duct with esophageal obturator, single use <*>

     

    161.283480 Gas flow sensor for breathing circuit, reusable

     

    162.185520 Breathing circuit tube holder

     

    163.191740 Air bubble / foam detector for heart-lung machine

     

    164.191500 Air bubble / fluid level detector for heart-lung machine

     

    165.109770 Detergent / detergent cleaning solution IVD for automated / semi-automated systems

     

    166.283380 Breathing apparatus mouthpiece, reusable

     

    167.283330 Breathing apparatus mouthpiece, single use <*>

     

    168.364520 Valsalva test mouthpiece, manometric

     

    169.350590 Mouthpiece for Valsalva test, standard <*>

     

    170.351540 Cardiopulmonary resuscitation mouthpiece / cover

     

    171.318110 Sheath for laryngeal airway

     

    172.289880 Endotracheal tube sheath, reusable

     

    173.289990 Sheath for endotracheal tube, single use <*>

     

    174.220960 Thermographic camera

     

    175.105850 Nasal cannula for oxygen supply during mechanical ventilation with constant positive pressure <*>

     

    176.136410 Standard nasal cannula for oxygen supply <*>

     

    177.135700 Catheter for installation of an endobronchial valve <*>

     

    178.124630 Mechanical exhalation valve, reusable

     

    179.124510 Mechanical exhalation valve, single use <*>

     

    180.236910 Exhalation valve with radio frequency sensor <*>

     

    181.262380 The valve is non-reversible, reusable

     

    182.321960 Non-reversible valve, single use <*>

     

    183.168130 Check valve, built-in, reusable

     

    184.168140 Check valve, built-in, single use <*>

     

    185.109060 Valve of positive pressure at the end of expiration, reusable

     

    186.108960 Valve of positive pressure at the end of expiration, single use <*>

     

    187.337110 Resistance valve for cardiopulmonary resuscitation, for inhalation / exhalation

     

    188.135690 Endobronchial valve

     

    189.151440 Y-connector for breathing circuit, reusable

     

    190.151450 Y-shaped connector for breathing circuit, single use <*>

     

    191.298760 Vacuum fast connector, female

     

    192.298770 Connector for quick vacuum connection, with plug

     

    193.250740 Nitrous oxide quick coupling, female

     

    194.250710 Quick coupling for nitrous oxide, with plug

     

    195.250830 Nitrous oxide / oxygen quick coupling, female

     

    196.250770 Quick connector for nitrous oxide / oxygen, with plug

     

    197.260200 Connector for a needleless connection with a direct-flow valve <*>

     

    198.182020 Connector for quick connection of compressed air source for surgical instruments, with female connector

     

    199.182030 Fast connection for compressed air supply for surgical instruments, with plug

     

    200.136690 Connector for quick connection of medical air cylinders, with plug

     

    201.136820 Connector for quick connection of medical air cylinders, with female connector

     

    202.275840 Connector for quick connection in the waste gas evacuation system, with plug

     

    203.275690 Connector for quick connection in the waste gas evacuation system, with female connector

     

    204.298870 Connector for quick connection in the system of supplying a mixture of helium and oxygen, with female connector

     

    205.298880 Connector for quick connection in the system of supplying a mixture of helium and oxygen, with plug connector

     

    206.110230 Reusable breathing circuit tube / mask connector

     

    207.327610 Breathing circuit tube / mask connector, single use, non-sterile <*>

     

    208.327640 Breathing circuit tube / mask connector, single use, sterile <*>

     

    209.256770 Low pressure tubing connector, reusable

     

    210.157680 Medical bedside console with communications inlets

     

    211.259390 Console with communications inlets, universal, with wall mounting

     

    212.259380 Console with communication inlets, universal, with ceiling mounting

     

    213.293550 Vacuum container for IVD saliva samples, with sodium azide <*>

     

    214.340600 Container for IVD analysis, single use <*>

     

    215.259790 Container for collection of tissue samples, non-specialized IVD, with formalin solution <*>

     

    216.259720 Container for collecting samples, non-specialized IVD, without additives, non-sterile <*>

     

    217.259780 Non-specialized IVD sample collection container, no additives, sterile <*>

     

    218.134590 Cryobiological container

     

    219.108710 General purpose laboratory container, reusable

     

    220.108750 General purpose laboratory container, sterile <*>

     

    221.113810 Portable oxygen concentrator

     

    222.191160 Stationary oxygen concentrator

     

    223.104010 Insulating suit

     

    224.181360 Surgical insulating suit

     

    225.188380 Surgical suit with cuffs <*>

     

    226.248320 Surgical suit, disposable, non-sterile <

     

    227.120210 Mechanical hospital bed

     

    228.131200 Hospital bed with hydraulic drive

     

    229.136210 Standard hospital bed with electric drive

     

    230.131980 Ultraviolet germicidal lamp

     

    231.172910 Cuff for tracheal tube <*>

     

    232.173780 Cuff for tracheostomy tube <*>

     

    233.271370 Reusable ventilator mask

     

    234.271390 Mask for artificial ventilation of the lungs, single use <*>

     

    235.109720 Reusable constant / biphasic positive airway pressure apparatus face mask

     

    236.109710 Disposable constant / biphasic positive airway pressure apparatus face mask <*>

     

    237.132380 Reusable face mask for respiratory tract protection

     

    238.367580 Disposable face mask for respiratory tract protection <*>

     

    239.109740 Oral mask for artificial ventilation of the lungs with constant / biphasic positive pressure

     

    240.181520 Reusable surgical mask

     

    241. 182450 Disposable surgical mask <*>

     

    242.283460 Breathing circuit bag, reusable

     

    243.283370 Breathing circuit bag, single use <*>

     

    244.292390 Electronic micropipette

     

    245.327110 Microplate IVD <*>

     

    246.327180 Microplate IVD film <*>

     

    247.157200 Patient monitoring system module, for pulse oximetry

     

    248.157130 Patient monitoring system module, multifunction

     

    249.289980 Endotracheal tube cuff pressure monitor

     

    250.135710 Set for determining the size of the endobronchial valve <*>

     

    251.206980 Kit for collection and transportation of samples with viruses <*>

     

    252.347240 Set for collection of samples of oropharyngeal discharge <*>

     

    253.349480 Kit for collection, handling and transport of samples

     non-specialized <*>

     

    254.152850 Kit for extraction / isolation of IVD nucleic acids

     

    255.332470 Set of clothes for surgical / examination <*>

     

    256.191560 Set of tubes for the heart-lung system <*>

     

    257.292810 Pipette tip <*>

     

    258.352690 IVD pipette tip <*>

     

    259.289870 Pump for manual injection of air into the endotracheal tube cuff

     

    260.188360 High-flow infusion pump with the possibility of heating the injected media

     

    261.183030 Infusion pump multichannel general purpose

     

    262.124530 General purpose infusion pump, mechanical, reusable

     

    263.333950 General purpose infusion pump, mechanical, single use <*>

     

    264.329460 General purpose infusion pump, battery powered

     

    265.260420 General purpose infusion pump, mains powered

     

    266.288180 Elastomeric infusion pump <*>

     

    267.264520 Centrifugal pump for heart-lung systems, with power supply

     

    268.191770 Centrifugal pump for the heart-lung system <*>

     

    269.249420 Hemostatic valve obturator <*>

     

    270.131520 Membrane intravascular oxygenator <*>

     

    271.115610 Extracorporeal membrane oxygenator <*>

     

    272.115570 Bubble extracorporeal oxygenator <*>

     

    273.152690 High-efficiency filtering air purifier, mobile

     

    274.152700 High-efficiency filtering air purifier, stationary

     

    275.228190 Laminar air flow tent

     

    276.335060 Laboratory thermostatic stirrer

     

    277.205280 Examination / treatment gloves, vinyl, powder-free <*>

     

    278.205290 Vinyl examination / treatment gloves, powdered <*>

     

    279.298450 Examination / procedural gloves made of guayule latex, powder-free <*>

     

    280.122540 Examination / procedural gloves made of Hevea latex, powder-free, non-sterile <*>

     

    281.351490 Examination / procedure gloves made of Hevea latex, powder-free, non-sterile, antibacterial <*>

     

    282.122560 Examination / procedural gloves made of Hevea latex, powdered <*>

     

    283.139350 Examination / procedure gloves made of polychloroprene, powder-free <*>

     

    284.139360 Examination / procedural gloves made of polychloroprene, powdered <*>

     

    285.311720 Examination / procedure gloves made of ethylene vinyl acetate, powder-free, unsterile <*>

     

    286.320790 Examination / procedure gloves, nitrile, powder-free, antibacterial <*>

     

    287.185830 Examination / procedure gloves, nitrile, powder-free, non-sterile <*>

     

    288.185850 Examination / procedure gloves, nitrile, powdered <*>

     

    289.321530 Examination / procedural gloves, polyisoprene, powder-free <*>

     

    290.349230 Examination / procedural gloves, polyisoprene, powdered <*>

     

    291.327170 General purpose laboratory plate <*>

     

    292.293370 Vacuum tube for taking blood samples IVD, without additives <*>

     

    293.293530 Vacuum tube for taking blood samples, IVD, without additives / without metal impurities <*>

     

    294.293500 Vacuum test tube for taking blood samples, IVD, with K2EDTA <*>

     

    295.293660 Test tube vacuum for taking blood samples IVD, with K3EDTA <*>

     

    296.293360 Vacuum test tube for taking blood samples, IVD, with K3EDTA and sodium fluoride <*>

     

    297.293570 A vacuum tube for taking blood samples, IVD, with a coagulation activator <*>

     

    298.293450 Vacuum tube for taking blood samples, IVD, with ammonium heparin and separating gel <*>

     

    299.293400 Vacuum tube for taking blood samples IVD, with potassium oxalate and sodium fluoride <*>

     

    300.293460 Vacuum tube for taking blood samples IVD, with lithium heparin and lithium iodoacetate <*>

     

    301.293480 Vacuum tube for taking blood samples, IVD, with lithium heparin and separating gel <*>

     

    302.293760 Vacuum tube for taking blood samples IVD, with lithium heparin <*>

     

    303.293420 Vacuum tube for taking blood samples, IVD, with sodium heparin <*>

     

    304.293540 Vial vacuum for taking blood samples IVD, with sodium citrate <*>

     

    305.293350 Vacuum tube for taking blood samples, IVD, with dextrose B citrate (ACD-B) <*>

     

    306.293440 Vacuum tube for taking blood samples, IVD, with dextrose citrate A (ACD-A) <*>

     

    307.293470 Vacuum tube for taking blood samples IVD, with CFDA <*>

     

    308.167480 A tube for collecting blood samples, non-vacuum, without impurities, IVD <*>

     

    309.167450 Tube for collecting blood samples, non-vacuum IVD, with lithium heparin <*>

     

    310.167550 Tube for collection of blood samples, non-vacuum IVD, with sodium citrate <*>

     

    311.167440 Tube for collecting blood samples, non-vacuum IVD, with separating gel <*>

     

    312.167430 Tube for collecting blood samples, non-vacuum IVD, with EDTA <*>

     

    313.264460 Centrifuge tube IVD, non-sterile <*>

     

    314.264440 Centrifuge tube IVD, sterile <*>

     

    315.218410 Telemetric pulse oximeter

     

    316.149980 Pulse Oximeter, Battery Powered

     

    317.150020 Pulse Oximeter, mains powered

     

    318.160170 Wash buffer solution for automatic immunochemiluminescence analyzers

     

    319.231790 Wash / wash buffer solution for immunochemistry IVD

     

    320.231970 Substrate solution for automatic immunochemiluminescent analyzers

     

    321.172970 Tracheal tube cuff expander

     

    322.324440 Reaction Cuvettes / Cuvettes for laboratory analyzer IVD, reusable

     

    323.324430 Reaction cuvettes / cuvettes for laboratory analyzer IVD, single use <*>

     

    324.108170 Outpatient recorder for body temperature monitoring

     

    325.172930 Vacuum regulator for trachea aspiration system

     

    326.191920 Cardiotomy reservoir <*>

     

    327.180770 Respirator for general use <*>

     

    328.181830 Surgical respirator <*>

     

    329.272240 Antiseptic napkin <*>

     

    330.358690 General purpose surgical suction system, pneumatic

     

    331. 358710 General purpose surgical suction system, electric

     

    332.347590 Room disinfection system with ultraviolet light

     

    333.126320 Infrared thermographic system

     

    334.191780 Heart-lung system, with a nerolic pump

     

    335.191810 Heart-lung machine, roller pump

     

    336.156250 Respiratory oxygen therapy system

     

    337.190840 System for monitoring the physiological parameters of several patients

     

    338.190850 System for monitoring the physiological parameters of one patient

     

    339.374930 SARS Nucleic Acid Detection System Coronavirus 2 (SARS-CoV-2) IVD

     

    340.209090 Mobile system for extracorporeal gas exchange

     

    341.182740 Surgical suction / irrigation system

     

    342.344690 Mixer of a gas mixture oxygen / air, for emergency

     

    343.298900 Mixer of helium and oxygen for obtaining breathing mixture

     

    344.165230 Breathing circuit connector, reusable

     

    345.165140 Breathing circuit connector, single use <*>

     

    346.139780 Spacer for nebulizer or inhaler, reusable

     

    347.345540 Spacer for nebulizer or inhaler, single use <*>

     

    348.289900 Duct stylet, reusable

     

    349.290000 Stiletto for airway, single use <*>

     

    350.218750 Heat / moisture exchanger / bacteria filter, non-sterile <*>

     

    351.300390 Thermometer for measuring the patient's body temperature with color indication <*>

     

    352.341680 Cordless patient thermometer, reusable

     

    353.341690 Wireless patient thermometer, single use <*>

     

    354.339240 Liquid crystal medical thermometer, reusable

     

    355.184110 Liquid crystal medical thermometer, single use <*>

     

    356.126390 Infrared thermometer for measuring the temperature of the patient's body, skin

     

    357.126370 Infrared thermometer for measuring the temperature of the patient's body, ear

     

    358.358080 Infrared thermometer for measuring the temperature of the patient's body, ear / skin

     

    359.335240 Capillary thermometer for measuring the patient's body temperature, based on gallium alloy

     

    360.213740 Capillary thermometer for measuring the patient's body temperature, mercury

     

    361.213720 Capillary thermometer for measuring the patient's body temperature, alcohol

     

    362.254890 Fiber optic thermometer with temperature sensor

     

    363.266210 Electronic thermometer for measuring the patient's body temperature in pulse mode

     

    364.190030 Electronic thermometer for continuous measurement of the patient's body temperature, powered from the mains

     

    365.190040 Electronic thermometer for continuous measurement of the patient's body temperature, battery-powered

     

    366.261720 Laboratory thermostat

     

    367.232840 Laboratory thermostat for clean rooms

     

    368.260440 General purpose thermostat

     

    369.298830 Vacuum tube, reusable

     

    370.298800 Vacuum tube, single use <*>

     

    371.191040 Suction / rinsing tube, single use <*>

     

    372.333030 Tube for monitoring pressure to the heart-lung system <*>

     

    373.348290 Tube for airway cuff inflation <*>

     

    374.132340 Airway cleaning / aspiration tube for emergency situations

     

    375.274010 Aerosol supply tube <*>

     

    376.334110 Spirometry / Lung Function Tubing

     

    377.275760 Tube for evacuation of waste anesthetic gases

     

    378.3332660 Gas sampling / monitoring breathing tube, reusable

     

    379.271240 Breathing tube for gas sampling / monitoring, single use <*>

     

    380.332650 Breathing tube for gas sampling / monitoring, single use, sterile <*>

     

    381.333510 Breathing tube for inhalation / exhalation branch pipe, reusable

     

    382.354450 Breathing tube for inhalation / exhalation branch pipe, single use, non-sterile <*>

     

    383.360480 Breathing tube for inhalation / exhalation branch pipe, single use, sterile <*>

     

    384.283260 Breathing circuit tube

     

    385.183640 Coaxial tube to the cylinder with nitrous oxide <*>

     

    386.351410 Low pressure pipe for general purpose gas, reusable

     

    387.250810 A pipe of low pressure for nitrous oxide

     

    388.136850 A pipe of low pressure for medical air

     

    389.357210 Reinforced tracheostomy tube, reusable

     

    390.16908 Reinforced tracheostomy tube, single use <*>

     

    391.349970 Tracheostomy tube, made individually

     

    392.136490 Tracheostomy tube, standard, reusable

     

    393.136500 Tracheostomy tube, standard, single use <*>

     

    394.135720 Endobronchial tube <*>

     

    395.218780 Antibacterial endotracheal tube <*>

     

    396.301700 Endotracheal tube for high-frequency artificial lung ventilation <*>

     

    397.279070 Endotracheal tube with suction cuff <*>

     

    398.136270 Standard endotracheal tube, reusable

     

    399.136260 Standard endotracheal tube, single use <*>

     

    400.269300 Endotracheal tube, laser-resistant <*>

     

    401.169050 Endotracheal tube, reinforced, reusable

     

    402.169100 Endotracheal tube, reinforced, single use <*>

     

    403.127430 Ultrasonic humidifier of respiratory air / gases

     

    404.173070 Humidifier for breathing mixtures without heating

     

    405.152090 Heated breathing gas humidifier

     

    406.182750 Laminar flow unit for surgery

     

    407.209360 Mobile laminar flow unit

     

    408.318650 Device for separating magnetic particles IVD, automatic

     

    409.318100 Device for pumping air from the cuff for the laryngeal airway

     

    410.318660 Device for preparation of IVD nucleic acid samples, automatic

     

    411.115660 Device for extracorporeal monitoring of blood gases / pH

     

    412.324930 Bacterial filter for medical gases, non-sterile, reusable

     

    413.318730 Bacterial filter for medical gases, non-sterile, single use <*>

     

    414.173800 Protective filter for tracheostomy <*>

     

    415.181090 Compressed air filter for surgical instruments

     

    416.110260 Replaceable filter for heat / moisture exchanger <*>

     

    417.325840 Filter / mouthpiece for testing lung function <*>

     

    418.327810 Medical gas flowmeter, dial

     

    419.327750 Medical gas flowmeter, with bourdon tube pressure gauge

     

    420.327780 Medical Gas Flowmeter, Thorpe Tube

     

    421.157240 Reusable patient gown

     

    422.157010 Disposable patient gown <*>

     

    423.129870 Insulating gown, reusable

     

    424.129880 Single-use insulating gown <*>

     

    425.129380 Operating gown, reusable

     

    426.129350 Disposable operating gown <*>

     

    427.164070 Reusable procedural gown

     

    428.164050 Disposable procedural gown <*>

     

    429.143910 Blood fridge

     

    430.261620 Laboratory refrigerator, basic

     

    431.215850 Pharmaceutical refrigerator

     

    432.352570 Laboratory refrigerator / freezer

     

    433.352580 Refrigerator / freezer for pharmaceutical facility

     

    434.321680 Blood storage refrigerator / freezer

     

    435.143900 Blood bank centrifuge

     

    436.248410 Microsample centrifuge

     

    437.117910 Floor-standing high-speed centrifuge

     

    438.274470 Floor-standing low-speed centrifuge, no cooling

     

    439.274480 Floor-standing low-speed centrifuge, with cooling

     

    440.260430 General purpose benchtop centrifuge

     

    441.214590 Cytological centrifuge

     

    442.274530 Protective screen for eyes <*>

     

    443.343600 Eye protection screen, reusable

     

    444.107700 Protective screen for the face <*>

     

    445.343590 Face shield, reusable

     

    446.344780 Kit for creating a "library" of IVD nucleic acids

    (Clause 446 was introduced by the Decree of the Government of the Russian Federation of December 28, 2021 N 2506)

     

    447.339880 Nucleic acid sequencing reagent kit IVD

    (Clause 447 was introduced by the Decree of the Government of the Russian Federation of December 28, 2021 N 2506)

     

    448.332060 IVD nucleic acid sequencer, new generation sequencing

    (Clause 448 was introduced by the Decree of the Government of the Russian Federation of December 28, 2021 N 2506)

     

    449.339870 IVD nucleic acid sequencer, Sanger sequencing

    (Clause 449 was introduced by the Decree of the Government of the Russian Federation of December 28, 2021 N 2506)

     

     

     

    --------------------------------

    <*> Disposable medical devices.

     

     

     

     

     

     

     

    Appendix N 2

    to the peculiarities of the appeal

    medical devices, including

    state registration of the series

    (batch) of a medical device

     

    INTELLIGENCE

    ABOUT MEDICAL DEVICES SUBMITTED TO THE FEDERAL SERVICE

    SURVEILLANCE IN HEALTHCARE

     

     

    List of changing documents

    (introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

     

    1. The name of the medical device (for registered medical devices - in accordance with the registration certificate).

    2. Number and date of registration certificate for a medical device (for registered medical devices).

    3. Option or model of a medical device (if any).

    4. Type code and name of the type of medical device in accordance with the nomenclature classification of medical devices by type, approved by the Ministry of Health of the Russian Federation.

    5. The name of the manufacturer of the medical device (for registered medical devices - in accordance with the registration certificate).

    6. Name of the country of the manufacturer of the medical device (for registered medical devices - in accordance with the registration certificate).

    7. Address of the place of manufacture of the medical device (for registered medical devices - in accordance with the registration certificate).

    8. Composition and equipment of the medical device (if any) and the list of accessories (if any) (for registered medical devices - in accordance with the registration certificate).

    9. Serial (batch) number, serial number.

    10. The volume of the batch (lot) or the number of serial numbers in pieces.

    11. Date of manufacture (manufacture) of the medical device.

    12. Shelf life (operation) of a medical device.

     13. Information about the applicant specified in clause 3 of the peculiarities of the circulation of medical devices, including state registration of a series (batch) of a medical device, approved by Decree of the Government of the Russian Federation of April 3, 2020 N 430 "On the peculiarities of the circulation of medical devices, including state registration of a series (batch) of a medical device "(full and abbreviated (if any) name, including the company name, organizational and legal form of a legal entity, its address, taxpayer identification number, main state registration number or surname, name and patronymic (if any), the address of the place of residence of the individual entrepreneur, the data of the document proving his identity, the main state registration number of the individual entrepreneur, telephone number and e-mail address).

    14. Information about the person who stores the batch (batch), the serial number of the medical device (full and abbreviated (if any) name, including the business name, organizational and legal form of the legal entity, its address, taxpayer identification number, main state registration number or surname, name, patronymic (if any) of an individual entrepreneur, address of residence, data of his identity document, main state registration number of an individual entrepreneur, telephone number and e-mail address).

    15. Information about the person to whom the series (batch) was sold, the serial numbers of the medical device (full and abbreviated (if any) name, including the company name, organizational and legal form of the legal entity, its address, taxpayer identification number , main state registration number or surname, name, patronymic (if any) of an individual entrepreneur, residence address, data of his identity document, main state registration number of an individual entrepreneur, telephone number and e-mail address).





联系我们:上海卡卢加机电设备检测中心/俄罗斯EAC认证机构中国代表处


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