BEUDAMED
    FDA Registration Active 🇫🇷 France

    Parietex Composite (PCO-OS)

    Reg #: 3002807295 · FEI: 3002807295 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IONISOS
    Registration Number
    3002807295
    FEI Number
    3002807295
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Z.A de L Aubree
    City
    SABLE-SUR-SARTHE
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K173796

    Owner / Operator

    Firm Name
    EPIONE BIDCO
    Operator Number
    10042490
    Address
    415 allee de Frenes, bat Squale
    City
    LIMONEST
    State
    Rhone
    Postal Code
    69760
    Country
    FR
    Correspondent
    Alexandra Basset

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7131159

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL

    Proprietary Names

    Parietex Composite (PCO-OS) Parietex Composite Parietex Optimized Composite Mesh (PCOX) Parietex Optimized Composite Mesh (PCO-OSX) Parietex Parietex Optimized Composite Mesh (PCO-FX) Parietex™ Hydrophilic Anatomical Mesh Parietex™ Hydrophilic 3-Dimensional Mesh Parietex™ Hydrophilic 2-Dimensional Mesh

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)