BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Assure Tech. (Hangzhou) Co., Ltd.

    SRN: CN-MF-000002170 · 2nd-5th Floor, Building 4, No. 1418-50 Moganshan Road, Gongshu District, 310011 Hangzhou, Zhejiang, China
    View on EUDAMED
    Basic UDI-DIs
    212
    Total Devices
    212
    On Market
    212
    Off Market
    0
    Certificates
    9
    Valid
    1
    Expiring < 6mo
    0
    Countries
    6

    Basic Information

    Address
    2nd-5th Floor, Building 4, No. 1418-50 Moganshan Road, Gongshu District, 310011 Hangzhou, Zhejiang, China
    Email
    [email protected]
    Phone
    +(86)571-81022698
    Website
    www.diareagent.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 212
    Classification
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    Eu Ivd General 203
    Eu Ivd Self Testing 7
    Eu Ivd Annex 2 List A 1
    Eu Ivd Annex 2 List B 1
    Device Types
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    Certificate Health

    Total
    9
    Valid
    1
    Expiring < 6mo
    0
    Expired / Withdrawn
    8
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV Section 4 CeCert/077/W/E.1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) HL 2074650-1 May 26, 2025
    IVDD Annex III Section 6 2020-IVD/DE-006/A May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) HL 202746520-1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) HL 202746520-1 May 26, 2025
    IVDD Annex III Section 6 CeCert/081/W/E.4 May 26, 2025
    IVDD Annex IV Section 4 244409553-200 May 26, 2025
    IVDD Annex III Section 6 1434-IVDD-078/2022 May 27, 2025
    IVDR QMS HX 2074650-1 Jun 12, 2029 Amended

    Market Presence

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

    🇦🇹 Austria 🇩🇪 Germany 🇫🇷 France 🇭🇷 Croatia 🇮🇹 Italy 🇳🇱 Netherlands

    Device Portfolio

    Name
    25-OH Vitamin D Chemiluminescence Immunoassay Test Kit
    6-Acetylmorphine FIA
    6-Monoacetylmorphine
    7-Amino clonazepam Rapid Test
    ADV FIA
    AFP FIA
    Acetaminophen
    Adenovirus FIA
    Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit
    Alprazolam Rapid Test
    Amphetamine FIA
    Amphetamine Rapid Test
    Anti-mullerian hormone FIA
    Astrovirus FIA
    Astrovirus Test
    Barbiturate FIA
    Barbiturate Rapid Test
    Benzodiazepine FIA
    Benzodiazepine Rapid Test
    Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip)
    Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip)
    Blood Glucose Test Strips
    Brucella Antiboby Test
    Buprenorphine Rapid Test
    C-Reactive Protein Rapid Test
    C. difficile GDH FIA
    C. difficile GDH Rapid Test
    C. difficile Toxin A FIA
    C. difficile Toxin B FIA
    CEA FIA
    CKMB FIA
    CLIN. CHEM. RT & POC - OTHER
    COVID-19 Antigen FIA
    COVID-19 Antigen Nasal Test Kit
    COVID-19 Antigen Rapid Test Device
    COVID-19 Antigen Saliva Test Kit
    COVID-19 Antigen Saliva Test Kit
    COVID-19 Neutralizing Antibody Rapid Test
    COVID-19&FLU A/B FIA
    COVID-19 & Influenza A/B Antigen Nasal Test Kit
    COVID-19 IgG Rapid Test
    COVID-19 IgG Test Kit
    CRP FIA
    Caffeine Rapid Test
    Calprotectin Rapid Test
    Campylobacter Rapid Test
    Cannabinol Rapid Test
    Carbohydrate Antigen 125 FIA
    Carbohydrate Antigen 15-3 FIA
    Carbohydrate Antigen 19-9 FIA
    View all 212 devices →