BEUDAMED
    FDA Registration Active 🇫🇷 France

    Tissue Expander Hemisphere 2ml

    Reg #: 9615745 · FEI: 3000314405 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    2
    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
    K010852

    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
    Expander, Tissue, Orbital NFM

    Proprietary Names

    Tissue Expander Hemisphere 2ml Tissue Expander Sphere 1ml Tissue Expander Sphere 2ml Tissue Expander Hemisphere 0,4ml Tissue Expander Sphere 3ml Tissue Expander Sphere 5ml Tissue Expander Hemisphere 0,9ml Tissue Expander Hemisphere 0,9ml/P Tissue Expander Sphere 4ml Tissue Expander Hemisphere 1,5ml

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device