BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    S.A. INSTRUMENTATION DIFRA

    Reg #: 9710334 · FEI: 3003244948 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    S.A. INSTRUMENTATION DIFRA
    Registration Number
    9710334
    FEI Number
    3003244948
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Industriestrasse 33
    City
    Eupen Liege
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K070670

    Owner / Operator

    Firm Name
    S.A. INSTRUMENTATION DIFRA
    Operator Number
    9045726
    Address
    RUE DE L'EGLISE 84, --
    City
    WELKENRAEDT
    State
    Liege
    Postal Code
    4840
    Country
    BE

    US Agent

    Business Name
    Secure Health, Inc
    Contact Name
    Daniel Scherer
    Address
    1729 Red Oak Run
    City
    Fort Wayne
    State
    IN
    ZIP
    46804
    Country
    US
    Email
    [email protected]
    Phone
    260 8044041 ext. 0

    Products

    Device Name Product Code
    Stimulator, Caloric-Water ETP
    Stimulator, Caloric-Air KHH
    Nystagmograph GWN
    Lens, Fresnel, Flexible, Diagnostic HJJ
    Drum, Opticokinetic HOW
    Device, Fixation, Ac-Powered, Ophthalmic HPL

    Proprietary Names

    AquaStar CoolStar AirStar NysStar PRO NysStar II Headstar NysStar II Easy Headstar Easy HeadStar V3 NysStar I NysStar I Ltd. VideoStar II VideoStar Monocular VideoStar Binocular VideoScoop (APL) VideoScoop USB Monocular VisioStar VertiTest II

    Establishment Types

    Manufacture Medical Device