BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OSYPKA GmbH

    Reg #: 3003923762 · FEI: 3003923762 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    OSYPKA GmbH
    Registration Number
    3003923762
    FEI Number
    3003923762
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Earl-H.-Wood-Str. 1
    City
    Rheinfelden Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K232261
    PMA Number
    P240014

    Owner / Operator

    Firm Name
    Osypka GmbH
    Operator Number
    10048738
    Address
    Earl-H.-Wood-Str. 1
    City
    Rheinfelden
    State
    Baden-Wurttemberg
    Postal Code
    79618
    Country
    DE
    Correspondent
    Nicola Osypka

    US Agent

    Business Name
    Biomedical Consulting
    Contact Name
    Alan Van Houten
    Address
    916 Ridgecrest Drive
    City
    Carver
    State
    MN
    ZIP
    55315
    Country
    US
    Email
    [email protected]
    Phone
    952 9392987

    Products

    Device Name Product Code
    Electrode, Pacemaker, Temporary LDF
    Implanted Tibial Electrical Urinary Continence Device QXM
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Cardiac Ablation Percutaneous Catheter LPB

    Proprietary Names

    OSYPKA TME pacing wires Revi Implant RIWO D-URS MAGiC Magnetic Interventional Ablation Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)