BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Orsiro

    Reg #: 3011574793 · FEI: 3011574793 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CORTRONIK GmbH
    Registration Number
    3011574793
    FEI Number
    3011574793
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Friedrich-Barnewitz-Str. 4a
    City
    Rostock-Warnemuende Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    PMA Number
    P170030

    Owner / Operator

    Firm Name
    BIOTRONIK AG
    Operator Number
    10024585
    Address
    Ackerstrasse 6
    City
    Buelach
    State
    Zurich
    Postal Code
    CH-8180
    Country
    CH

    US Agent

    Business Name
    BIOTRONIK, INC.
    Contact Name
    Jon Brumbaugh
    Address
    6024 JEAN RD
    City
    Lake Oswego
    State
    OR
    ZIP
    97035
    Country
    US
    Email
    [email protected]
    Phone
    503 4518310

    Products

    Device Name Product Code
    Coronary Drug-Eluting Stent NIQ

    Proprietary Names

    Orsiro Orsiro Mission

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)