BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Occlutech ASD Occluder and Occlutech Pistol Pusher

    Reg #: 3014616394 · FEI: 3014616394 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Occlutech GmbH
    Registration Number
    3014616394
    FEI Number
    3014616394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Winzerlaer Strasse 2
    City
    Jena Thuringia
    Country
    DE

    Regulatory Submissions

    PMA Number
    P200032

    Owner / Operator

    Firm Name
    Occlutech Holding AG
    Operator Number
    10084004
    Address
    Feldstrasse 22
    City
    Schaffhausen
    State
    CH-SH
    Postal Code
    8200
    Country
    CH

    US Agent

    Business Name
    OCCLUTECH US LLC
    Contact Name
    Christine Lee
    Address
    9325 Upland Lane North, Suite 315
    City
    Maple Grove
    State
    MN
    ZIP
    55369
    Country
    US
    Email
    [email protected]
    Phone
    404 4227739

    Products

    Device Name Product Code
    Transcatheter Septal Occluder (Atrial) OZG

    Proprietary Names

    Occlutech ASD Occluder and Occlutech Pistol Pusher

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device