BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Instrumed GmbH dba Avalign German Specialty Instruments

    Reg #: 8010372 · FEI: 3007290840 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Instrumed GmbH dba Avalign German Specialty Instruments
    Registration Number
    8010372
    FEI Number
    3007290840
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Unter Buchsteig
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K040855

    Owner / Operator

    Firm Name
    Avalign Technologies
    Operator Number
    10051835
    Address
    8727 Clinton Park Drive
    City
    Fort Wayne
    State
    IN
    Postal Code
    46825
    Country
    US
    Correspondent
    Heidi Funston

    US Agent

    Business Name
    Avalign Technologies
    Contact Name
    Heidi Funston
    Address
    10275 W Higgins Rd Suite 920
    City
    Rosemont
    State
    IL
    ZIP
    60018
    Country
    US
    Email
    [email protected]
    Phone
    260 4841500

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)