BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Colplast1941 (RB) - SpeediCath Standard Male

    Reg #: 3008102042 · FEI: 3002924544 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health Radeberg GMBH
    Registration Number
    3008102042
    FEI Number
    3002924544
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Juri-Gagarin-Strasse 15
    City
    Radeberg Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K180258

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    STERIS Corporation
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Catheter, Urethral GBM

    Proprietary Names

    Colplast1941 (RB) - SpeediCath Standard Male Colplast1941 (VL1) - SpeediCath Accessories

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)