BEUDAMED
    FDA Registration Active 🇫🇷 France

    Retinal Sleeve

    Reg #: 9615745 · FEI: 3000314405 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FCI SAS
    Registration Number
    9615745
    FEI Number
    3000314405
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 rue Carl Zeiss
    City
    BESANCON Doubs
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K963219

    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 Sleeve Retinal Band Retinal Sponge Retinal Strip Retinal bands & strips Retinal Tire (Type 276) Retinal Tire BAND FOR REINFORCING SCLERA AT THE BACK OF THE EYE

    Establishment Types

    Manufacture Medical Device