BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Nantong EgensBiotechnology Co.,Ltd.

    SRN: CN-MF-000021561 · Building 15, Building 12(west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone,, 226010 Nantong, China
    View on EUDAMED
    Basic UDI-DIs
    35
    Total Devices
    35
    On Market
    6
    Off Market
    29
    Certificates
    3
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

    Basic Information

    Address
    Building 15, Building 12(west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone,, 226010 Nantong, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 35
    Classification
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    Eu Ivd General 27
    Eu Ivd Self Testing 7
    Eu Ivd Annex 2 List B 1
    Device Types
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    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    3
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) No.V1 063367 0017 May 26, 2025
    IVDD Annex III Section 6 No. 1434-IVDD-228/2022 May 27, 2025
    IVDD Annex III Section 6 No. 1434-IVDD-231/2022 May 27, 2025

    Device Portfolio

    Name
    COVID-19 IgG/IgM Rapid Test Kit
    Antigens Multiplex(FluA-FluB-SARS-CoV-2)
    Dengue IgM/IgG test cassette
    Dengue NS1 antigen test cassette
    Dengue NS1/IgM/IgG test cassette
    Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)
    Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)
    Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)
    Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)
    Diagnostic kit for Antibody to Treponema Pallidum (Colloidal Gold)
    Diagnostic kit for anti-HAV IgM( Colloidal Gold)
    Fast Diagnostic Screening Test for Sperm Concentration
    Fecal Occult Blood (FOB)Test
    Follicle Stimulating Hormone (FSH) Test
    H.Pylori Antibody (HP) Test
    Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit
    Monkeypox Virus (MPV) Antigen Test Kit (Colloidal Gold)
    Monkeypox Virus (MPV) IgG/IgM Antibody Test Kit (Colloidal Gold)
    Monkeypox Virus (MPV) Nucleic Acid Test Kit
    Multiple Drugs of Abuse Rapid Tests
    Multiple Drugs of Abuse Rapid Tests
    Multiple Rapid Real-Time PCR kit for Detection of SARS-CoV-2 (Fluorescent PCR Method）
    Ovulation (LH) Test for Self Testing
    Pregnancy Test for Self Testing
    Pregnancy Test for Self Testing
    Prostate Specific Antigen (PSA) Test
    Reaction Tube With Cap
    SARS-CoV-2 Ag Duo Home
    SARS-CoV-2 Antigen Rapid Test
    SARS-CoV-2 Antigen Rapid Test kit
    SARS-CoV-2 Multiplex Antibody Rapid Test Kit
    SARS-CoV-2 Neutralizing Antibody Rapid Test Kit
    SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test
    Typhoid IgG/IgM test cassette
    Urinalysis Reagent Strips