BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    INNOVATION MEDITECH GMBH

    Reg #: 3004003391 · FEI: 3004003391 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    INNOVATION MEDITECH GMBH
    Registration Number
    3004003391
    FEI Number
    3004003391
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MAX-PLANCK-STR. 31
    City
    UNNA North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K200580

    Owner / Operator

    Firm Name
    INNOVATION MEDITECH GMBH
    Operator Number
    9057092
    Address
    MAX-PLANCK-STRASSE 31
    City
    UNNA
    State
    North Rhine-Westphalia
    Postal Code
    59423
    Country
    DE

    US Agent

    Business Name
    DREVE AMERICA CORP.
    Contact Name
    Robert Nickoloff
    Address
    6477 City West Pkwy
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    651 3249494

    Products

    Device Name Product Code
    Aligner, Bracket, Orthodontic ECQ
    Kit, Earmold, Impression LDG
    Hearing Aid, Air-Conduction, Prescription ESD
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Material, Impression Tray, Resin EBH
    Plate, Base, Shellac EEA
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Indirect Bonding Tray Sonopal soft Lack E Sonopal hart Lack Al Impression trays Drill guide

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device