BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH

    Reg #: 3005049530 · FEI: 3005049530 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH
    Registration Number
    3005049530
    FEI Number
    3005049530
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    IM LETTEN 1
    City
    Feldkirch Vorarlberg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K150718

    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

    US Agent

    Business Name
    Agency for Medical Innovations, Inc.
    Contact Name
    Andrew Bendheim
    Address
    89 Front St Ste 309
    City
    Marblehead
    State
    MA
    ZIP
    01945
    Country
    US
    Email
    [email protected]
    Phone
    781 9901806

    Products

    Device Name Product Code
    Ligator, Hemorrhoidal FHN
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Instrument, Ligature Passing And Knot Tying HCF
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Catheter, Pediatric, General & Plastic Surgery GBN
    Carrier, Ligature GEJ
    Laparoscope, Gynecologic (And Accessories) HET
    Containment System, Laparoscopic Power Morcellation, With Instrument Port PMU

    Proprietary Names

    RAR Flexi Probes Wi-3 Fixation Nut Wi-3 Arm Wi-3 HAL-RAR Unit A.M.I. HAL Knotpusher / AHK 007 A.M.I. Knotpusher Premium / APK 001 FiXcision A.M.I. HAL-Doppler II System A.M.I. HAL-II Adaptor USA A.M.I. Recto Anal Repair Sleeve A.M.I. Recto Anal Repair Probe A.M.I. HAL Needleholder A.M.I. HAL Knotpusher A.M.I. HAL Handle A.M.I. HAL-II Electronic System RAR Flexi Probe RAR Precision Probe A.M.I. HAL / RAR System Comfort Drain Comfort Drain Grasper A.M.I. HAL Needleholder / AHN 006 i-Cut Power Supply Typ A i-Cut i-Cut Power Supply More-Cell Bag More-Cell-System More-Cell-System 30

    Establishment Types

    Manufacture Medical Device