BEUDAMED
    FDA Registration Active 🇫🇷 France

    Symbotex™ Composite Mesh

    Reg #: 9615742 · FEI: 3003521774 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SOFRADIM PRODUCTION
    Registration Number
    9615742
    FEI Number
    3003521774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    116 AVENUE DU FORMANS
    City
    TREVOUX Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K220586

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    US Agent

    Business Name
    Covidien LLC
    Contact Name
    Tania Pearson
    Address
    15 Hampshire Street
    City
    Mansfield
    State
    MA
    ZIP
    02048
    Country
    US
    Email
    [email protected]
    Phone
    916 8138456

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL

    Proprietary Names

    Symbotex™ Composite Mesh Progrip™ Self-Gripping Polyester Mesh Versatex™ Monofilament Mesh Parietex™ 2D 3D Anatomical Mesh

    Establishment Types

    Manufacture Medical Device