BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PACE 203H

    Reg #: 9681449 · FEI: 3007486998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSYPKA MEDICAL GMBH
    Registration Number
    9681449
    FEI Number
    3007486998
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Albert-Einstein-Strasse 3
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K020896

    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

    Proprietary Names

    PACE 203H Model 3085 PACE 203

    Establishment Types

    Manufacture Medical Device