BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Uneo, Uneo Skinguard

    Reg #: 9616494 · FEI: 3003117657 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    101
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
    Registration Number
    9616494
    FEI Number
    3003117657
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Naeder-Strasse 15
    City
    DUDERSTADT Lower Saxony
    Country
    DE

    Owner / Operator

    Firm Name
    Ottobock SE & Co. KGaA
    Operator Number
    8010097
    Address
    Max-Naeder-Strasse 15
    City
    Duderstadt
    State
    Lower Saxony
    Postal Code
    37115
    Country
    DE

    US Agent

    Business Name
    Otto Bock HealthCare LP
    Contact Name
    Caleb Beck
    Address
    3820 West Great Lakes Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84120
    Country
    US
    Email
    [email protected]
    Phone
    801 9746647

    Products

    Device Name Product Code
    Cover, Limb IPM

    Proprietary Names

    Uneo, Uneo Skinguard Prosthetic Sock dis. Terry-prox. Cotton Prosthetic Skin Natural gloves for women Functional Cosmesis Genium (Knee Part) AK Prosthetic Shrinker Myo prosthetic Skin Natural gloves for men Foam Cover Myo prosthetic Skin Natural gloves for women Sticky Spot, Brim Pad Sticky Cover Prosthetic Sock - Plain Knit Prosthetic gloves for children Soft Touch Prosthetic Sock, BK, Wool Foam Cover, Tibial-square Derma Seal Trans Ped SKEO 3D TT Liner Dynamic Vacuum System Skeo Skinguard Uneo Foot Cosmetics Prosth. Sock, Terry Cloth Cosmetic Foam Cover Compression Liner Locking Bebionic skin silicone black Functional Cosmesis Genium Compression Shrinker for transtib.amp.CCL1 AxonSkin Silicone Glove Liner fit kit Special Prosth. Sock for Ob Liner, Nylon Cosmetic foam cover Derma Seal Double forte AK Adapt Liner Connection Plate AeroLink Hybrid Liner Caleo Skeo Sealing Caleo 3D Skeo Sealing 3D Functional cosmesis Genium X4 Uneo Flex Liner Myo prosthetic AxonSkin glove visual, black BK Prosthetic Shrinker Skeo Pure Myo prosthetic gloves for adolescents and men Genium X4 Protective cover, short C-Leg Guard Compression Shrinker for transfem.amp.CCL1 Myo prosthetic gloves for women Functional stocking Footshell 1C30 Pre-Shaped, Cored, Flexed AK Cover Compression Liner Cushion Skeo 3D C-Leg Protector Myo prosthetic Skin Natural gloves for adolescents and women Prosthetic Skin Natural gloves for children Skeo Unique Special Pros.Sock for Liner, Terry Cloth Foam Cover, pediatric BK, TT Skeo Sealing TT Functional Stocking Custom Sleeve MySkin Myo Genium X3 Protective Cover Myo prosthetic gloves for children Physio inner hands for men Uneo Unique Custom Liner Gaitor Sleeve MySkin Move Shield insert Myo prosthetic gloves for adolescents and women Kenevo Protective Cover Harmony Sleeve Functional knee part Myo prosthetic Skin Natural gloves for children Physio inner hands for women C-Leg Protective Cover w/o shield Harmony Taper Sleeve Prosthetic gloves for adolescents and men Physio inner hands for children Uneo Skinguard Triton Footshell Prosthetic Sock dis. Cotton-prox. Terry Bebionic skin silicone ProSeal SIL Liner Prosthetic Skin Natural gloves for adolescents Uneo 3D, Fresh Foam Cover, AK Myo prosthetic AxonSkin glove natural for women Cosmetic foam cover for hip ex. Silicon Gel Liner Skeo Functional Cosmesis C-Leg SKEO 3D Prosthetic gloves for women Functional Cosmesis C-Leg (Knee Part) Myo prosthetic AxonSkin glove natural for men Thigh kit/Magnetic closure mHand Skin Skeo up Daily Assist Genium X4 Protective cover, long

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device