BEUDAMED
    EU Manufacturer ๐Ÿ‡จ๐Ÿ‡ณ China Active

    Daan Gene Co., Ltd.

    SRN: CN-MF-000025799 ยท Xiangshan Road, Science Park, High & New Technology Development District No. 19, 510665 Guangzhou, China
    View on EUDAMED
    Basic UDI-DIs
    127
    Total Devices
    194
    On Market
    194
    Off Market
    0
    Certificates
    5
    Valid
    0
    Expiring < 6mo
    0
    Countries
    8

    Basic Information

    Address
    Xiangshan Road, Science Park, High & New Technology Development District No. 19, 510665 Guangzhou, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 105
    Eu Ivdr 22
    Classification
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    Eu Ivd General 100
    Eu Ivd Class A 22
    Eu Ivd Annex 2 List B 3
    Eu Ivd Annex 2 List A 2
    Device Types
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    Certificate Health

    Total
    5
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    5
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) CeCert/043/W/E.1 May 27, 2025
    IVDD Annex IV Section 4 CeCert/042/W/E.1 May 27, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/045/W/E.1 May 27, 2025
    IVDD Annex IV Section 4 CeCert/044/W/E.1 May 27, 2025
    IVDD Annex IV (excluding sections 4, 6) CeCert/072/W/E.1 May 27, 2025

    Market Presence

    Devices from this manufacturer are available in 8 countries across Europe.

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ท๐Ÿ‡ด Romania

    Device Portfolio

    Name
    AVIAN INFLUENZA - NA REAGENTS
    Automatic Nucleic Acid Extraction Instrument
    Automatic Nucleic Acid Extraction Instrument
    Automatic Nucleic Acid Extraction Instrument
    CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
    CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
    CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
    DENGUE VIRUS - NA REAGENTS
    DENGUE VIRUS - NA REAGENTS
    DENGUE VIRUS - NA REAGENTS
    EBV - NA REAGENTS
    EBV - NA REAGENTS
    EBV - NA REAGENTS
    EBV - NA REAGENTS
    EBV - NA REAGENTS
    EBV - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    ENTEROVIRUS - NA REAGENTS
    GENETIC TESTS - OTHER
    GENETIC TESTS - OTHER
    GONOCOCCAL DETECTION BY NA REAGENTS
    GONOCOCCAL DETECTION BY NA REAGENTS
    GONOCOCCAL DETECTION BY NA REAGENTS
    GONOCOCCAL DETECTION BY NA REAGENTS
    GONOCOCCAL DETECTION BY NA REAGENTS
    GONOCOCCAL DETECTION BY NA REAGENTS
    GONOCOCCAL DETECTION BY NA REAGENTS
    HANTAVIRUS / BUNYAVIRUS - NA REAGENTS
    HEPATITIS B VIRUS - NA REAGENTS
    HEPATITIS C VIRUS - NA REAGENTS
    HISTOLOGICAL SAMPLES ANALYSERS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    INFLUENZA & PARA INFLUENZA - NA REAGENTS
    IVD GENERAL USE CONSUMABLE DEVICES - OTHER
    IVD GENERAL USE CONSUMABLE DEVICES - OTHER
    IVD GENERAL USE CONSUMABLE DEVICES - OTHER
    IVD GENERAL USE CONSUMABLE DEVICES - OTHER
    IVD GENERAL USE CONSUMABLE DEVICES - OTHER
    View all 194 devices โ†’