BEUDAMED
    4,922 results · 41ms · Sources: EU EUDAMED, US FDA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)

    NR-F350

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·NANORAY Co.,Ltd.·2 devices

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

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)

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

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)

    ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC

    FDA 510(k)
    FDA Class 2 ·Dental

    MRI system, accessory Risk Class I

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Esaote S.p.A.·11 devices

    301081783

    Certificate
    MDD Annex V·President Dental GmbH·ENTE CERTIFICAZIONE MACCHINE SRL·14 Basic UDI-DIs

    5-926+200-2105

    Certificate
    MDD Annex II (excluding section 4)·FIXIER SA DE CV·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI

    Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DZ 2048293-1

    Certificate
    MDR QA·Jiangxi 3L Medical Products Group Co., Ltd.·TÜV Rheinland LGA Products GmbH

    MDD-193

    Certificate
    MDD Annex V·Biolux Technology GmbH·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ·2 Basic UDI-DIs

    193

    Certificate
    MDD Annex V·Biolux Technology GmbH·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ·1 Basic UDI-DI

    Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Unit, Syringe, Air And/Or Water

    FDA classification
    FDA Class 1 ·Unit, Syringe, Air And/Or Water

    Fab, Fitc, Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Fab, Fitc, Antigen, Antiserum, Control

    Chemistry Analyzer

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices

    PMS2 (MRQ-28) Mouse Monoclonal Antibody

    FDA registration
    CELL MARQUE CORP.·1 product·🇺🇸 United States

    Detection Systems

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·WellMed BV·1 device