BEUDAMED
    1,328 results · 41ms · Sources: EU EUDAMED, US FDA

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

    TNP/MDR/0018/3830/2024

    Certificate
    MDR QMS·FOLDIX MEDICAL INŻ. UWE WERNER PETRASCH·TUV NORD Polska Sp. z o.o

    DEVIPOL mgr inz. Zbigniew Matysiewicz

    Importer
    🇵🇱 Poland

    Acid, Hydroxyazobenzene-Benzoic, Albumin

    FDA classification
    FDA Class 2 ·Acid, Hydroxyazobenzene-Benzoic, Albumin

    Devices, Breath Trapping, Alcohol

    FDA classification
    FDA Class 1 ·Devices, Breath Trapping, Alcohol

    FOLDIX MEDICAL INŻ. UWE WERNER PETRASCH

    Importer
    🇵🇱 Poland

    Unicen 21

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Álvarez Redondo, S.A.·2 devices

    Immunoassay Multi Control

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