BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GR-10 guide I MSI

    Reg #: 3014888923 · FEI: 3014888923 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PRO3DURE MEDICAL GMBH
    Registration Number
    3014888923
    FEI Number
    3014888923
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Burgberg 13
    City
    Iserlohn North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K231775

    Owner / Operator

    Firm Name
    pro3dure medical GmbH
    Operator Number
    10059691
    Address
    Am Burgberg 13
    City
    Iserlohn
    State
    North Rhine-Westphalia
    Postal Code
    58642
    Country
    DE
    Correspondent
    Denis Gerasimov

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY

    Proprietary Names

    GR-10 guide I MSI GR-19.1 OA I MSI GR-19.1 OA UCAN Print Splint

    Establishment Types

    Manufacture Medical Device