BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    VivaChek Biotech (Hangzhou) Co., Ltd.

    SRN: CN-MF-000012160 · Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone, 311100 Hangzhou, Zhejiang, China
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    Basic UDI-DIs
    176
    Total Devices
    176
    On Market
    176
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone, 311100 Hangzhou, Zhejiang, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 175
    Eu Ivdr 1
    Classification
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    Eu Ivd General 168
    Eu Ivd Annex 2 List B 7
    Eu Ivd Class A 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    Expired / Withdrawn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 IV (excluding sections 4, 6) HL 2135127-1 May 26, 2025

    Market Presence

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

    🇫🇷 France

    Device Portfolio

    Name
    VivaDiag Monkeypox Virus IgM/IgG Rapid Test
    Heart Fatty Acid Binding Protein Test Kit (FIA)
    17α-Hydroxyprogesterone Control Solution (FIA)
    25-Hydroxyvitamin D3 (25-OH-D3) Test Kit (FIA) 
    Adenovirus Control Solution (FIA)
    Adrenocorticotropic Hormone Control Solution (FIA)
    Aldosterone Control Solution (FIA)
    Amphetamine Test Kit (FIA)
    Amphetamine(AMP) Rapid Test
    Amphetamine(AMP) Rapid Test
    Anti-Mullerian Hormone Test Kit (FIA)
    Anti-cyclic Citrullinated Peptide Antibody Control Solution (FIA)
    Anti-cyclic Citrullinated Peptide Antibody Test Kit (FIA)
    Autoimmune Control Solution (FIA)
    B-type Brain Natriuretic Peptide Control Solution (FIA)
    B-type Brain Natriuretic Peptide Test Kit
    Benzodiazepine(BZO) Rapid Test
    Benzodiazepine(BZO) Rapid Test
    Beta Amyloid 40 Test Kit (FIA)
    Beta Human Chorionic Gonadotropin Control Solution (FIA)
    Beta Human Chorionic Gonadotropin Test Kit (FIA) 
    Beta-2 Microglobulin Control Solution (FIA)
    Beta-2 Microglobulin Test Kit (FIA)
    Bone Markers Control Solution (FIA)
    Buprenorphine(BUP) Rapid Test
    Buprenorphine(BUP) Rapid Test
    COVID-19 IgM/IgG / SARS-CoV-2 IgM/IgG
    Calprotectin Control Solution (FIA)
    Calprotectin Test Kit (FIA)
    Carbohydrate Antigen 125 Control Solution (FIA)
    Carbohydrate Antigen 125 Test Kit (FIA)
    Carbohydrate Antigen 15-3 Control Solution (FIA)
    Carbohydrate Antigen 19-9 Control Solution (FIA)
    Carbohydrate Antigen 19-9 Test Kit (FIA) 
    Carcino-embryonic Antigen Control Solution (FIA)
    Cardiac Combo (cTnI/CK-MB) Control Solution (FIA)
    Cardiac Combo (cTnI/CK-MB) Test Kit (FIA) 
    Cardiac Combo (cTnI/CK-MB/MY0) Test Kit (FIA) 
    Cardiac Combo (cTnI/CK-MB/MYO) Control Solution (FIA)
    Cardiac Troponin I Test Kit (FIA)
    Cardiac Troponin T Test Kit (FIA) 
    Cortisol Test Kit (FIA)
    Creatine Kinase-MB Test Kit (FIA) 
    Cyclosporin A Control Solution (FIA)
    Cyclosporin A Test Kit (FIA)
    Cystatin C Control Solution (FIA)
    Cystatin C Test Kit (FIA)
    Cytokeratin 19 Fragment (CYFRA21-1) Control Solution (FIA)
    Cytokeratin 19 Fragment (CYFRA21-1) Test Kit (FIA)
    D-Dimer Control Solution (FIA)
    View all 176 devices →