BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Nanjing Genscript Diagnostics Technology Co., Ltd.

    SRN: CN-MF-000025148 · Ruihong Zhihui Park, No.2289 Tianyuan East Road (Jiangning High-tech Park) No.2289, 211100 Nanjing City, China
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    Basic UDI-DIs
    2
    Total Devices
    2
    On Market
    2
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Ruihong Zhihui Park, No.2289 Tianyuan East Road (Jiangning High-tech Park) No.2289, 211100 Nanjing City, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 2
    Classification
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    Eu Ivd General 1
    Eu Ivd Self Testing 1
    Device Types
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    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex III Section 6 1434-IVDD-110/2022 May 27, 2025

    Market Presence

    Devices from this manufacturer are available in 1 country across Europe.

    🇩🇪 Germany

    Device Portfolio

    Name
    CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]
    cPass