BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BIOTRONIK AG

    Reg #: 8043892 · FEI: 3002808050 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    BIOTRONIK AG
    Registration Number
    8043892
    FEI Number
    3002808050
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ACKERSTRASSE 6
    City
    BULACH Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K102211
    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
    Teleflex, Inc
    Contact Name
    Divya Raman
    Address
    3015 Carrington Mill Boulevard
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    612 4231738

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Coronary Drug-Eluting Stent NIQ
    Stent, Coronary MAF
    Stent, Iliac NIO
    Stent, Superficial Femoral Artery NIP
    Coronary Covered Stent NIV
    Catheter, Percutaneous DQY
    Introducer, Catheter DYB
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    Cruiser-18 Galeo Oscar Pantera Leo Passeo-14 Pantera Pro Passeo-18 Passeo-35 Xeo Orsiro Orsiro Mission PRO-Kinetic Energy Astron Pulsar-18 Pulsar-18 T3 Papyrus Passeo-35 HP Fortress Fortress 5/6F

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device