BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PSW 1301.U

    Reg #: 9610139 · FEI: 3002806500 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    BIOTRONIK SE & CO. KG
    Registration Number
    9610139
    FEI Number
    3002806500
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WOERMANNKEHRE 1
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    PMA Number
    P000009

    Owner / Operator

    Firm Name
    BIOTRONIK SE & CO. KG
    Operator Number
    9018331
    Address
    6024 Jean Road
    City
    Lake Oswego
    State
    OR
    Postal Code
    97035
    Country
    US

    US Agent

    Business Name
    BIOTRONIK, Inc.
    Contact Name
    Jon Brumbaugh
    Address
    6024 Jean Rd
    City
    Lake Grove
    State
    OR
    ZIP
    97035
    Country
    US
    Email
    [email protected]
    Phone
    503 9707014

    Products

    Device Name Product Code
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Defibrillator, Implantable, Dual-Chamber MRM

    Proprietary Names

    PSW 1301.U ICS 3000 Renamic

    Establishment Types

    Manufacture Medical Device