BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Biatain Silicone AG

    Reg #: 9610694 · FEI: 3002806731 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLOPLAST A/S
    Registration Number
    9610694
    FEI Number
    3002806731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HOLTEDAM 1
    City
    HUMLEBAEK Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K191536

    Owner / Operator

    Firm Name
    Coloplast Corp.
    Operator Number
    8010144
    Address
    1601 West River Road North
    City
    Minneapolis
    State
    MN
    Postal Code
    55411
    Country
    US

    US Agent

    Business Name
    COLOPLAST CORP.
    Contact Name
    Jason Woehrle
    Address
    1601 West River Road N
    City
    Minneapolis
    State
    MN
    ZIP
    55411
    Country
    US
    Email
    [email protected]
    Phone
    612 7302063

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    Biatain Silicone AG

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility