BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GR-10 guide

    Reg #: 3014888923 · FEI: 3014888923 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    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
    K211415

    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
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Positioner, Tooth, Preformed KMY

    Proprietary Names

    GR-10 guide GR-22 flex dima Print Splint clear GR-19 OA STRUCTOMER SPLINT GR-20 MJF ACRY Print RU-005 Guide FLOW Hard Splint

    Establishment Types

    Manufacture Medical Device