BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Shanghai Chemtron Biotech Co., Ltd.

    SRN: CN-MF-000018072 · No. 518, Qingdai Rd., International Medical Park, Pudong, 201318, Shanghai, PEOPLE'S REPUBLIC OF CHINA , 201318 Shanghai, China
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    Basic UDI-DIs
    15
    Total Devices
    15
    On Market
    15
    Off Market
    0
    Certificates
    2
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

    Basic Information

    Address
    No. 518, Qingdai Rd., International Medical Park, Pudong, 201318, Shanghai, PEOPLE'S REPUBLIC OF CHINA , 201318 Shanghai, China
    Email
    [email protected]
    Phone
    86-17521018699
    Website
    www.chemtronbio.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 15
    Classification
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    Eu Ivd General 7
    Eu Ivd Self Testing 6
    Eu Ivd Annex 2 List B 2
    Device Types
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    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) V1 076482 0004 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) No.V1 076482 0004 May 26, 2025

    Device Portfolio

    Name
    Chemtrue ® COVID-19 Ag Rapid Test (Colloidal Gold)
    Chemtrue ® COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Saliva)
    ALBUMIN INCL. UALBUMIN RT & POC
    CHLAMYDIA AG - RT & POC
    Chemtrue ® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)
    Chemtrue ®COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Nasal Swab)
    Chemtrue ®® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold)
    Chemtrue ®® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)
    Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)
    FSH - RT & POC
    H. PYLORI - RT & POC
    HCG - RT & POC
    LH - RT & POC
    PSA - RT & POC
    SPECIFIC PROTEINS RT & POC - OTHER