BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

    SRN: CN-MF-000013495 · 10th Street(East), Hangzhou Economic & Technological Development Zone No. 139, 310018 Hangzhou, China
    View on EUDAMED
    Basic UDI-DIs
    91
    Total Devices
    115
    On Market
    115
    Off Market
    0
    Certificates
    3
    Valid
    0
    Expiring < 6mo
    0
    Countries
    6

    Basic Information

    Address
    10th Street(East), Hangzhou Economic & Technological Development Zone No. 139, 310018 Hangzhou, China
    Email
    [email protected]
    Website
    https://www.genesis-ivd.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 86
    Eu Ivdr 3
    Eu Mdr 2
    Classification
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    Eu Ivd General 80
    Eu Ivd Self Testing 6
    Eu Ivd Class A 3
    Eu Md Class 1 2
    Device Types
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    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    3
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex III Section 6 1434-IVDD-261/2022 May 27, 2025
    IVDD Annex III Section 6 1434-IVDD-261-2022 May 27, 2025
    IVDD Annex III Section 6 1434-IVDD-219/2022 May 27, 2025

    Market Presence

    Devices from this manufacturer are available in 6 countries across Europe.

    🇧🇪 Belgium 🇨🇾 Cyprus 🇬🇷 Greece 🇪🇸 Spain 🇳🇱 Netherlands 🇵🇹 Portugal

    Device Portfolio

    Name
    PCT/IL-6 Rapid Test (FIA)
    ADV Antigen Rapid Test Device
    ADV/RSV Antigen Rapid Test Device
    ANTICHEK SARS-CoV-2 (COVID-19) Antigen Test
    Adenovirus Antigen Rapid Test
    Astrovirus Antigen Rapid Test
    B. pertussis Antigen Rapid Test
    BacTrans Swabs
    BacTrans Swabs
    BacTrans Swabs
    BacTrans Swabs
    BacTrans swabs
    BloodPrime
    C. difficile GDH & Toxin A+B Combo Rapid Test
    C. difficile GDH & Toxin A/B Combo Rapid Test
    COVID-19 IgG/IgM Rapid Test Device [EN]
    COVID-19 Neutralization Ab+ Rapid Test
    COVID-19 Neutralization Antibody Rapid Test
    COVID-19 Total Antibody Rapid Test
    COVID-l9 Antigen Rapid Test Device
    CRP/MxA Combo Rapid Test
    CTX-M β-lactamases Rapid Test
    Calprotectin Rapid Test
    Campylobacter Antigen Rapid Test
    Candida albicans /Gardnerella vaginalis/Trichomonas vaginalis antigen Combo Rapid Test
    Carbapenemase Rapid Test
    Cryptosporidium Antigen Rapid Test
    Dengue IgG/IgM Rapid Test Device
    Dengue IgG/IgM/NS1 Combo Rapid Test Device
    Dengue NS1 Rapid Test Device
    EBNA IgG Rapid Test
    EBV-VCA IgG Rapid Test
    EZER COVID-19 Antigen Rapid Test
    EZER COVID-19 Antigen Rapid Test
    EZER COVID-19 Antigen Rapid Test
    EZER Flu & COVID-19 Antigen Duo Rapid Test
    EZER Flu & COVID-19 Antigen Duo Rapid Test
    EZER Flu & COVID-19 Antigen Duo Rapid Test
    EZER NAAT SARS-CoV-2 real-time RT-PCR Kit
    EZER NAAT SARS-CoV-2 real-time RT-PCR Kit
    Enterovirus 71 IgM  Rapid Test
    Extended NTM
    Extended NTM
    Extended NTM
    Extended NTM
    Extended NTM
    Extended NTM
    Extended NTM
    Extended NTM
    Extended ViralTrans
    View all 115 devices →