BEUDAMED
    39 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Eu Ivd Class C × Kind: Kit × Clear all

    Ultra-Low PSA Control (UL PSA Control)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·1 device

    Total Prostate Specific Antigen(CLIA)、Total PSA Calibrators

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    PSA total IRMA KIT

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·1 device

    PSA free IRMA KIT

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·1 device

    Free Prostate Specific Antigen (CLIA)、Free PSA Calibrators

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Chemclin Diagnostics Co., Ltd.·4 devices

    Bilirubin Total (Bil-T) Kit (DSA Method)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    Bilirubin Direct Kit (DSA Method)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    HemosIL Heparin

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL Heparin Calibrators

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL Apixaban Calibrators

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL Dabigatran Controls

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL Dabigatran Calibrators

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL Direct Thrombin Inhibitor Assay

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL ISI Calibrate

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL INR Validate

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL ReadiPlasTin

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL RecombiPlasTin 2G (20 mL)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL PT-Fibrinogen HS PLUS

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device

    HemosIL APTT-SP

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory Company·1 device