BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Pantera LEO

    Reg #: 3018805824 · FEI: 3018805824 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOTRONIK APM PTE. LTD
    Registration Number
    3018805824
    FEI Number
    3018805824
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Kaki Bukit View #03-24/34 Techview, Lobby C
    City
    Singapore South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K163660

    Owner / Operator

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

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX

    Proprietary Names

    Pantera LEO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)