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    Hangzhou Laihe Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

    CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·On the market

    LYHER

    Device
    EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·On the market

    DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

    Device
    EU IVDR · Eu Ivd Class A ·Hangzhou Laihe Biotech Co., Ltd.·On the market·0 countries

    GONOCOCCAL ANTIGEN DETECTION

    Device
    EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country

    STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]

    Device
    EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country

    Chlamydia Antigen Rapid Test Kit

    Device
    EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·3 countries

    NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·1 device

    COVID-19 and Influenza A/B Antigen Test Kit for self-testing

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·1 device

    BIOSYNEX FLACON URINE URITOP +2

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Hangzhou Laihe Biotech Co., Ltd.·1 device

    Gonorrhea Antigen Rapid Test Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

    Chlamydia and Gonorrhea Antigen Rapid Test Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

    Chlamydia Antigen Rapid Test Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

    CeCert/068/W/E.2

    Certificate
    IVDD Annex III Section 6·Hangzhou Laihe Biotech Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    HL 2069313-1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Hangzhou Laihe Biotech Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI