BEUDAMED
    5,215 results · 47ms · Sources: EU EUDAMED, US FDA

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

    Medisono

    FDA UDI
    Medisono, LLC·B369MUS05227·

    MCI Medical Care Instruments GmbH

    Importer
    🇩🇪 Germany

    Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR

    Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

    FDA classification
    FDA Class 1 ·Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

    0068/QPZ-DM/172-2020

    Certificate
    MDD Annex V·JMI SYRINGES & MEDICAL DEVICES LTD.·MTIC InterCert S.r.l.·34 Basic UDI-DIs

    HD 60147227 0001

    Certificate
    MDD Annex II Section 4·Shenzhen JCR Medical Technology Limited Company·TÜV Rheinland LGA Products GmbH·5 Basic UDI-DIs

    KCI Manufacturing Unlimited Company

    Authorized representative
    🇮🇪 Ireland·3 Manufacturers

    DCI DENTAL MALZEMELERİ VE TİCARET ANONİM ŞİRKETİ

    Importer
    🇹🇷 Türkiye

    Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

    FDA classification
    FDA Class 2 ·Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

    Azo Dye, Calcium

    FDA classification
    FDA Class 2 ·Azo Dye, Calcium

    Zimmerman (Spectrophotometric), 17-Ketosteroids

    FDA classification
    FDA Class 1 ·Zimmerman (Spectrophotometric), 17-Ketosteroids

    Analyzer, Gas, Nitrogen, Gaseous-Phase

    FDA classification
    FDA Class 2 ·Analyzer, Gas, Nitrogen, Gaseous-Phase

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR

    25-OH-Vitamin D Total (CLIA)、25-OH-Vitamin D Total Calibrators

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

    MED-RAS GmbH Regulatory Affairs Service

    Authorized representative
    🇩🇪 Germany·18 Manufacturers·235 Devices

    Piccolo Basic Metabolic Panel

    FDA UDI
    ABAXIS, INC.·EABA40000241·The Piccolo® Basic Metabolic Panel, used with t...

    Agfa NV

    Importer
    🇧🇪 Belgium·8 Manufacturers