BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    i-limb digits diagnostic kit

    Reg #: 3003764610 · FEI: 3003764610 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSSUR H/F
    Registration Number
    3003764610
    FEI Number
    3003764610
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GRJOTHALS 1-5
    City
    REYKJAVIK
    Country
    IS

    Owner / Operator

    Firm Name
    OSSUR Americas
    Operator Number
    9026971
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    US Agent

    Business Name
    Ossur
    Contact Name
    Katla Axelsdottir
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3823833

    Products

    Device Name Product Code
    Hand, External Limb Component, Powered IQZ

    Proprietary Names

    i-limb digits diagnostic kit Compact Electrode kit i-limb digits refinement kit i-LIMB Skin Active My Biosim LIVINGSKIN app DermaHair i-LIMB Skin Contour Demo-limb i-limb power pack i-Digits Access Battery assembly kit i-LIMB Skin Natural Thumb skin tip Biosim-pro i-Limb Access Digit skin tip Seasonguard i-Limb Ultra Remote Electrode kit i-LIMB Skin Match Virtu-limb i-Limb Quantum i-Limb Ultra Titanium Grip chip i-Digits i-Digits Quantum i-Limb Quantum titanium i-Limb access titanium My i-Limb

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility