BEUDAMED
    FDA Registration Active 🇲🇺 Mauritius

    Retinal Tire

    Reg #: 3004467263 · FEI: 3004467263 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FCI SUD
    Registration Number
    3004467263
    FEI Number
    3004467263
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VEL INDUSTRIAL COMPLEX, ROYAL ROAD
    City
    MAPOU LECLEZIO GOODLANDS Riviere du Rempart
    Country
    MU

    Regulatory Submissions

    510(k) Number
    K980816

    Owner / Operator

    Firm Name
    Carl Zeiss Meditec, Inc.
    Operator Number
    9053564
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    Postal Code
    94568
    Country
    US

    US Agent

    Business Name
    CARL ZEISS MEDITEC USA, INC.
    Contact Name
    Paul Swift
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    ZIP
    94568
    Country
    US
    Email
    [email protected]
    Phone
    817 9258507

    Products

    Device Name Product Code
    Implant, Orbital, Extra-Ocular HQX

    Proprietary Names

    Retinal Tire Eptfe Retinal implants ePTFE DUCOURNAU ® BAND 2 x 7 mm ePTFE HALF-SPONGE 2.5 x 7.5 mm ePTFE SPONGE 4 mm ePTFE SPONGE 3 x 5 mm ePTFE SPONGE 3 mm ePTFE SPONGE 5 mm 4 x 3 mm ePTFE SPONGE (CHAUVAUD) 9 mm ePTFE STRIP (DESIGNED BY O. LEQUOY) ePTFE DUCOURNAU ® BAND 2.5 x 5.5 mm ePTFE SPONGE 2 x 5 mm ePTFE BAND 2.1 x 5.5 mm

    Establishment Types

    Manufacture Medical Device