BEUDAMED
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    Hangzhou Realy Tech Co.,Ltd.

    Manufacturer
    🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

    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

    Assure Tech. (Hangzhou) Co., Ltd.

    Manufacturer
    🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

    LYHER

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

    HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

    COVID-19 & Influenza A/B Antigen Nasal Test Kit

    Device
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country

    SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab)

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

    Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)

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

    Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）

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

    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

    HIV Rapid Test Device (Whole blood/Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

    K751416D

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

    K601416D

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

    COVID-19 & Influenza A/B Antigen Nasal Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

    Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech 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

    CeCert/077/W/E.1

    Certificate
    IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/100/W/E.1

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

    CeCert/025/W/E.1

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

    CeCert/081/W/E.4

    Certificate
    IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI