BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Dreve Otoplastik GmbH

    Reg #: 3003610251 · FEI: 3003610251 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    59
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Dreve Otoplastik GmbH
    Registration Number
    3003610251
    FEI Number
    3003610251
    Status
    Active
    Expiry Year
    2026
    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
    Otoscope ERA
    Lubricant, Patient KMJ
    Hearing Aid, Air-Conduction, Prescription ESD
    Orthosis, Moldable, Supportive, Skin Protective MNE
    Kit, Earmold, Impression LDG

    Proprietary Names

    Otoferm Creme Fotoplast S hart VarioScreen NanoScreen Lack Biopor AB RT Lack Lack B matt FotoTec SL.E Biopor UV-S Fotoplast Lack M Fotofix Lack B FotoTec SL.A Libby Horn Thermosoft Lack FotoTec DLP.flex 70/90 Biopor Marker eco Biopor AB NanoScreen Soft Lack Fotoplast S IO Fotoplast S IO lv Anchor Part Connection Biopor AB fluoreszent Otoferm Protect Fotoplast Lack 3 Arc tubing connection Lack B eco FotoTec DLP.A BioTec FotoTec Repair Pre-bent tubing Biopor AB UV Lack Biopor AB light Otopren Biopor AB monitoring Fotoplast Gel Biopor AB Xtreme Small nylon tubing SK 87 Silicone glue Silicone tubing Thermosoft FotoScreen Glusil SoftTouch Lack Tube end piece Biopor AB Xtrack Tubing FotoTec DLP.C Otoform A soft Otoform Xpand Otoform Ak Otoform Kc Impression syringe (standard, CIC) Hardener paste Otoform Ak X T Mixing canulas Otoform A softX Mixing canulas Impression pads (standard, CIC, vented) Otoform A flex

    Establishment Types

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