BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    SpeediCath Soft

    Reg #: 9613662 · FEI: 3002919051 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDISCAN GMBH & CO. KG
    Registration Number
    9613662
    FEI Number
    3002919051
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BAD HALLER STRASSE 34
    City
    KREMSMUNSTER Oberosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K200142

    Owner / Operator

    Firm Name
    MEDISCAN GMBH & CO. KG
    Operator Number
    9033053
    Address
    BAD HALLER STRASSE 34, --
    City
    KREMSMUNSTER
    State
    Oberosterreich
    Postal Code
    A-4550
    Country
    AT
    Correspondent
    MARKUS - NIEDERREITER

    US Agent

    Business Name
    GREINER BIO-ONE NORTH AMERICA, INC.
    Contact Name
    Manfred Abel
    Address
    4238 Capital Drive
    City
    Monroe
    State
    NC
    ZIP
    28110
    Country
    US
    Email
    [email protected]
    Phone
    704 2617821

    Products

    Device Name Product Code
    Catheter, Urethral GBM

    Proprietary Names

    SpeediCath Soft

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)