BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Luna Gold

    Reg #: 8010629 · FEI: 3001180585 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COLTENE/WHALEDENT GMBH & CO. KG
    Registration Number
    8010629
    FEI Number
    3001180585
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RAIFFEISENSTRASSE 30
    City
    LANGENAU Baden-Wurttemberg
    Country
    DE

    Owner / Operator

    Firm Name
    COLTENE Holding AG
    Operator Number
    9047609
    Address
    FELDWIESENSTRASSE 20, --
    City
    ALTSTAETTEN
    State
    Sankt Gallen
    Postal Code
    9450
    Country
    CH

    US Agent

    Business Name
    COLTENE/WHALEDENT INC.
    Contact Name
    Tricia Cregger
    Address
    235 Ascot Parkway
    City
    Cuyahoga Falls
    State
    OH
    ZIP
    44223
    Country
    US
    Email
    [email protected]
    Phone
    330 9168904

    Products

    Device Name Product Code
    Cotton, Roll EFN

    Proprietary Names

    Luna Gold ROEKO Parotimat ROEKO Cotton-roll ROEKO Lunamat REOKO Comprecap ROEKO Solomat-N ROEKO Parotisroll ROEKO Cotton Pellets ROEKO Luna ROEKO Roll-o-mat ROEKO Solomat-Click ROEKO Comprecap (anatomic)

    Establishment Types

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