BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OSYPKA MEDICAL GMBH

    Reg #: 9681449 · FEI: 3007486998 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    OSYPKA MEDICAL GMBH
    Registration Number
    9681449
    FEI Number
    3007486998
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Albert-Einstein-Strasse 3
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K123916

    Owner / Operator

    Firm Name
    Osypka Medical GmbH
    Operator Number
    9029408
    Address
    Albert-Einstein-Strasse 3, --
    City
    Berlin
    State
    DE-NOTA
    Postal Code
    D-12489
    Country
    DE
    Correspondent
    Thilo J Thuemecke

    US Agent

    Business Name
    OSYPKA MEDICAL, INC.
    Contact Name
    Markus Osypka
    Address
    1252 Via Barranca
    City
    La Jolla
    State
    CA
    ZIP
    92037
    Country
    US
    Email
    [email protected]
    Phone
    858 4540600

    Products

    Device Name Product Code
    Pulse-Generator, Pacemaker, External DTE
    Tester, Pacemaker Electrode Function DTA
    Plethysmograph, Impedance DSB

    Proprietary Names

    PSA 100 PSA 200 ICON AESCULON PACE 203H PACE 203 Model 3085 Medtronic 5391 PACE 101H Model 3077 PACE 101

    Establishment Types

    Manufacture Medical Device