BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    A.M.I. HAL Needleholder

    Reg #: 3005049530 · FEI: 3005049530 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AGENCY FOR MEDICAL INNOVATIONS GMBH
    Registration Number
    3005049530
    FEI Number
    3005049530
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    IM LETTEN 1
    City
    Feldkirch Vorarlberg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K061831

    Owner / Operator

    Firm Name
    AGENCY FOR MEDICAL INNOVATIONS GMBH
    Operator Number
    9068871
    Address
    IM LETTEN 1, --
    City
    FELDKIRCH, VORARLBERG
    State
    AT-NOTA
    Postal Code
    A 6800
    Country
    AT
    Correspondent
    Tanja - Kinzl

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    A.M.I. HAL Needleholder A.M.I. Recto Anal Repair Sleeve A.M.I. Recto Anal Repair Probe A.M.I. HAL Knotpusher A.M.I. HAL-II Adaptor USA A.M.I. HAL Handle A.M.I. HAL-Doppler II System A.M.I. HAL-II Electronic System RAR Precision Probe A.M.I. HAL / RAR System RAR Flexi Probe

    Establishment Types

    Manufacture Medical Device