BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Zhejiang Orient Gene Biotech Co., Ltd

    SRN: CN-MF-000017965 · East Yangguang Avenue, Dipu Street, Anji 3787#, 313300 Huzhou,Zhejiang, China
    View on EUDAMED
    Basic UDI-DIs
    48
    Total Devices
    48
    On Market
    48
    Off Market
    0
    Certificates
    0
    Valid
    0
    Expiring < 6mo
    0
    Countries
    6

    Basic Information

    Address
    East Yangguang Avenue, Dipu Street, Anji 3787#, 313300 Huzhou,Zhejiang, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 34
    Eu Ivdr 14
    Classification
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    Eu Ivd General 34
    Eu Ivd Class B 13
    Eu Ivd Class A 1
    Device Types
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    Certificate Health

    No certificates registered for this manufacturer.

    Market Presence

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

    🇩🇪 Germany 🇪🇸 Spain 🇫🇷 France 🇮🇹 Italy 🇵🇹 Portugal 🇬🇧 United Kingdom

    Device Portfolio

    Name
    Adenovirus Antigen Rapid Test Cassette (Swab)
    Adenovirus Antigen Rapid Test Cassette (Swab)
    Automatic Biochemistry Analyzer
    Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)
    Clinical Emergency Lyophilized Kit 15
    Electrolyte & Renal Function Lyophilized Kit 11
    Fecal Occult Blood Rapid Test Cassette (Feces)
    Fecal Occult Blood Rapid Test Strip (Feces)
    General Chemistry I Lyophilized Kit 18
    General Chemistry II Lyophilized Kit 18
    General Chemistry III Lyophilized Kit 15
    HAV IgM Rapid Test Cassette (Serum/Plasma)
    Influenza A & B Ag Rapid Test Cassette (Swab)
    Influenza A & B Ag Rapid Test Cassette (Swab)
    Liver Function Lyophilized Kit 14
    Monkeypox Virus Detection Kit (Fluorescence PCR)
    Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma)
    Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
    Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)
    Myocardial Enzyme and Lipid Lyophilized Kit 10
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    One Step Multi-Drug Test Dip Card (Urine)
    Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)
    Procalcitonin Semi-Quantitative Rapid Test Strip (Whole Blood/Serum/Plasma)
    RSV Antigen Rapid Test Cassette (Swab)
    Rapid COVID-19 + Influenza Antigen Test
    Renal Function Glucose and Lipid Lyophilized Kit 10
    Rotavirus Rapid Test Cassette (Feces)
    Strep A Rapid Test Cassette (Throat Swab)
    Strep A Rapid Test Strip (Throat Swab)
    Syphilis Ab Rapid Test Cassette (Serum/Plasma)
    Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)
    Syphilis Ab Rapid Test Strip (Serum/Plasma)
    Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma)
    Total IgE Rapid Test Cassette (Serum/Plasma)
    Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)
    Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)