BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Fotoplast Lack 3

    Reg #: 3003610251 · FEI: 3003610251 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    47
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Dreve Otoplastik GmbH
    Registration Number
    3003610251
    FEI Number
    3003610251
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MAX-PLANCK-STR. 31
    City
    UNNA North Rhine-Westphalia
    Country
    DE

    Owner / Operator

    Firm Name
    DREVE OTOPLASTIK GMBH
    Operator Number
    9028387
    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
    Hearing Aid, Air-Conduction, Prescription ESD

    Proprietary Names

    Fotoplast Lack 3 Anchor Part Connection Fotoplast S IO Thermosoft Lack Biopor AB Xtrack Biopor AB NanoScreen Soft Lack BioTec FotoTec Repair Biopor UV-S FotoScreen Fotoplast Gel Biopor AB UV Lack Thermosoft Lack B matt FotoTec SL.E Biopor AB fluoreszent Otoferm Protect Biopor AB light Otopren FotoTec DLP.flex 70/90 Small nylon tubing Fotoplast S hart Fotoplast S IO lv VarioScreen Lack B FotoTec SL.A Fotofix Biopor AB RT Lack Lack B eco Silicone tubing FotoTec DLP.C Glusil Biopor AB monitoring SK 87 Silicone glue Fotoplast Lack M Arc tubing connection Libby Horn Pre-bent tubing FotoTec DLP.A SoftTouch Lack Tube end piece Biopor Marker eco Biopor AB Xtreme FotoTec DLP.B NanoScreen Lack Tubing

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)