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

    Watch Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. for changes

    We'll email you when it registers new devices, or a certificate is issued or withdrawn.

    Get notified when Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. changes

    We'll email you about new devices, new certificates and withdrawals for this manufacturer.

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

    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    3
    Certificates by Expiry Year
    Loading...
    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 →