BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    SpeediCath Standard

    Reg #: 3008262278 · FEI: 3008262278 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Coloplast Hungary, KFT
    Registration Number
    3008262278
    FEI Number
    3008262278
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kerek utca 3
    City
    Tatabanya
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K180258

    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
    Catheter, Urethral GBM

    Proprietary Names

    SpeediCath Standard

    Establishment Types

    Repack or Relabel Medical Device