BEUDAMED
    EU Manufacturer πŸ‡¨πŸ‡³ China Active

    Nanjing Synthgene Medical Technology Co., Ltd.

    SRN: CN-MF-000023810 Β· Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin Subdistrict, Qixia District, Nanjing City,, 210000 Nanjing, China
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    Basic UDI-DIs
    83
    Total Devices
    83
    On Market
    83
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    9

    Basic Information

    Address
    Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin Subdistrict, Qixia District, Nanjing City,, 210000 Nanjing, China
    Email
    [email protected]
    Phone
    +86(025)83696681
    Website
    www.syngenemed.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 82
    Eu Ivdr 1
    Classification
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    Eu Ivd General 81
    Eu Ivd Class A 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    Expired / Withdrawn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-173/2022 May 27, 2025

    Market Presence

    Devices from this manufacturer are available in 9 countries across Europe.

    πŸ‡¦πŸ‡Ή Austria πŸ‡§πŸ‡ͺ Belgium πŸ‡©πŸ‡ͺ Germany πŸ‡©πŸ‡° Denmark πŸ‡ͺπŸ‡Έ Spain πŸ‡«πŸ‡· France πŸ‡±πŸ‡» Latvia πŸ‡³πŸ‡± Netherlands πŸ‡΅πŸ‡Ή Portugal

    Device Portfolio

    Name
    ALC Rapid Test Kit (Colloidal gold method)
    COC Rapid Test Kit (Colloidal gold method)
    KET Rapid Test Kit (Colloidal gold method)
    MOP Rapid Test Kit (Colloidal gold method)
    OXY Rapid Test Kit (Colloidal gold method)
    PCP Rapid Test Kit (Colloidal gold method)
    PPX Rapid Test Kit (Colloidal gold method)
    TCA Rapid Test Kit (Colloidal gold method)
    THC Rapid Test Kit (Colloidal gold method)
    6-MAM Rapid Test Kit (Colloidal gold method)
    AMPΒ  Rapid Test Kit (Colloidal gold method)
    APAP Rapid Test Kit (Colloidal gold method)
    Adenovirus Rapid Test Kit (Colloidal gold method)
    BAR Rapid Test Kit(Colloidal gold method)
    BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)
    BNP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)
    BUP Rapid Test Kit (Colloidal gold method)
    BZO Rapid Test Kit (Colloidal gold method)
    Bacterial vaginosis Rapid Test Kit (Colloidal gold method)
    CK-MB Rapid Test Kit (Colloidal gold method)
    CK-MB Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)
    COT Rapid Test Kit (Colloidal gold method)
    COVID-19 IgMIgG Antibody Rapid Detection Kit (Colloidal gold method)
    CRP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)
    Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)
    Cervical Pre-cancer And Cancer Rapid Test Kit (Colloidal gold method)
    Cryptococcal Antigen Rapid Test Kit (Colloidal gold method)
    D-Dimer Rapid Test Kit (Colloidal gold method)
    D-Dimer Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)
    Dengue NS1 Rapid Test Kit (Colloidal gold method)
    EDDP Rapid Test Kit (Colloidal gold method)
    ETG Rapid Test Kit (Colloidal gold method)
    Fetal Fibronectin Rapid Test Kit (Colloidal gold method)
    G17 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)
    Giardia Lamblia Rapid Test Kit (Colloidal gold method)
    H-FABP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)
    HC-10 Portable Colloidal Gold Immunoassay Analyzer
    HSV 12 Antigen Rapid Test Kit (Colloidal gold method)
    IGFBP-1 Rapid Test Kit (Colloidal gold method)
    IL-6 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)
    K2 Rapid Test Kit (Colloidal gold method)
    LSD Rapid Test Kit (Colloidal gold method)
    MDMA Rapid Test Kit (Colloidal gold method)
    MDPV Rapid Test Kit (Colloidal gold method)
    METΒ  Rapid Test Kit (Colloidal gold method)
    MOP/MET/KET/MDMA/THC/COC Rapid Test Kit (Colloidal gold method)
    MOP/MET/MDMA Rapid Test Kit (Colloidal gold method)
    MQL Rapid Test Kit (Colloidal gold method)
    MTD Rapid Test Kit (Colloidal gold method)
    MTHP Rapid Test Kit (Colloidal gold method)
    View all 83 devices β†’