BEUDAMED
    19 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Authorized Representative: Medical Technology Promedt Consulting Gmb H ×

    PCL Inc.

    Manufacturer
    🇰🇷 South Korea·1 Basic UDI-DI·1 Device

    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

    Device
    EU IVDR · Eu Ivd Class A ·PCL Inc.·On the market

    Biomech Innovations AG

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·ITALCERT SRL and ITALCERT SRL

    Comerge AG

    Manufacturer
    🇨🇭 Switzerland·TUV Rheinland Italia SRL

    PCLOK II

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·PCL Inc.·1 device

    VFLS

    Device
    EU MDD · Eu Md Class 3 ·Biomech Innovations AG·On the market·4 countries

    VFLS

    Device
    EU MDD · Eu Md Class 3 ·Biomech Innovations AG·On the market·4 countries

    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

    5.0mm Variable Fixation Locking Screw - stainless steel

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Biomech Innovations AG·1 device

    5.0 mm Variable Fixation Locking Screw - titanium

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Biomech Innovations AG·1 device

    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

    447-00-02

    Certificate
    MDD Annex II (excluding section 4)·Biomech Innovations AG·ITALCERT SRL·1 Basic UDI-DI

    447-00-02-DM

    Certificate
    MDD Annex II (excluding section 4)·Biomech Innovations AG·ITALCERT SRL·1 Basic UDI-DI

    ITH 2426703 1

    Certificate
    MDR QMS·Comerge AG·TUV Rheinland Italia SRL

    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

    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