BEUDAMED
    5,920 results · 38ms · Sources: EU EUDAMED, US FDA

    2022/MDD

    Certificate
    MDD Annex II (excluding section 4)·Idrom LT S.L.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·1 Basic UDI-DI

    Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    United Sports Brands Europe

    Importer
    🇧🇪 Belgium·2 Manufacturers

    OneApp

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·SBO Hearing A/S·1 device

    ChestEye

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Oxipit, UAB·1 device

    Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    Ldt, Unmet Need Within An Integrated Healthcare System

    FDA classification
    FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

    Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

    FDA classification
    FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

    Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    FDA classification
    FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    Pierced Ear/Entry Cleaning Tray

    FDA classification
    FDA Class 1 ·Pierced Ear/Entry Cleaning Tray

    OFTALMEDICA SRL

    Importer
    🇮🇹 Italy·13 Manufacturers

    W.M.BLOSS, S.A

    Importer
    🇪🇸 Spain·20 Manufacturers

    SANOTEK

    Importer
    🇫🇷 France·15 Manufacturers

    Deklene II

    FDA registration
    Sterigenics U.S., LLC·4 products·🇺🇸 United States

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    RIOMAVIX LTD

    Authorized representative
    🇪🇸 Spain·400 Manufacturers·4531 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices