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    Filters Authorized Representative: Sungo Europe B.V. × Manufacturer: Nantong Egens Biotechnology Co.,Ltd. × Clear all

    No. 1434-IVDD-228/2022

    Certificate
    IVDD Annex III Section 6·Nantong EgensBiotechnology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    No. 1434-IVDD-231/2022

    Certificate
    IVDD Annex III Section 6·Nantong EgensBiotechnology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    No.V1 063367 0017

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Nantong EgensBiotechnology Co.,Ltd.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

    Multiple Drugs of Abuse Rapid Tests

    Device
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·No longer on the market

    SARS-CoV-2 Antigen Rapid Test kit

    Device
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·No longer on the market

    Ovulation (LH) Test for Self Testing

    Device
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·On the market

    Follicle Stimulating Hormone (FSH) Test

    Device
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·On the market

    Fast Diagnostic Screening Test for Sperm Concentration

    Device
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·On the market

    Prostate Specific Antigen (PSA) Test

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Nantong EgensBiotechnology Co.,Ltd.·On the market

    Pregnancy Test for Self Testing

    Device
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·On the market

    Pregnancy Test for Self Testing

    Device
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·On the market

    Multiple Drugs of Abuse Rapid Tests

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·1 device

    SARS-CoV-2 Antigen Rapid Test kit

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·1 device

    Pregnancy Test for Self Testing

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·1 device

    Ovulation (LH) Test for Self Testing

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·1 device

    Follicle Stimulating Hormone (FSH) Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·1 device

    Fast Diagnostic Screening Test for Sperm Concentration

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·1 device

    Prostate Specific Antigen (PSA) Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Nantong EgensBiotechnology Co.,Ltd.·1 device

    Pregnancy Test for Self Testing

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nantong EgensBiotechnology Co.,Ltd.·1 device