BEUDAMED
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    Diagnostics for the Real World Ltd

    Manufacturer
    🇺🇸 United States

    Abon Biopharm(Hangzhou) Co., Ltd

    Manufacturer
    🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS

    HCV ANTIBODY -RT & POC

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

    HBSAG - RT & POC

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

    Lunit Inc.

    Manufacturer
    🇰🇷 South Korea·2 Basic UDI-DIs·5 Devices·3 Importers

    HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

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

    HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

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

    Lunit INSIGHT DBT

    Device
    EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·27 countries

    Lunit INSIGHT DBT

    Device
    EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·20 countries

    Lunit INSIGHT CXR

    Device
    EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·20 countries

    Lunit INSIGHT CXR

    Device
    EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·30 countries

    Lunit INSIGHT MMG

    Device
    EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·30 countries

    No. 11 0497 QS/NB

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs

    No. 11 0498 CN/NB

    Certificate
    IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs

    Lunit INSIGHT CXR

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Lunit Inc.·2 devices

    Lunit INSIGHT MMG

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Lunit Inc.·3 devices