BEUDAMED
    FDA Registration Active 🇫🇷 France

    3-D MATRIX EUROPE SAS

    Reg #: 3012263097 · FEI: 3012263097 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    0
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    3-D MATRIX EUROPE SAS
    Registration Number
    3012263097
    FEI Number
    3012263097
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 chemin des Petites Brosses, 2nd Floor
    City
    Caluire et Cuire Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K253924

    Owner / Operator

    Firm Name
    3-D MATRIX EUROPE SAS
    Operator Number
    10084567
    Address
    11 chemin des Petites Brosses, 2nd Floor
    City
    Caluire et Cuire
    State
    Rhone
    Postal Code
    69300
    Country
    FR
    Correspondent
    Audrey VION

    US Agent

    Business Name
    3-D Matrix, Inc.
    Contact Name
    Alan Miskewicz
    Address
    1234 Chestnut St, Ste 205
    City
    Newton
    State
    MA
    ZIP
    02464
    Country
    US
    Email
    [email protected]
    Phone
    781 3739020

    Products

    Device Name Product Code
    Hemostatic Device For Endoscopic Gastrointestinal Use QAU
    Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Oral Wound Dressing OLR
    Protective Coating, Mucoadhesive Application, For The Rectal Mucosa PHN

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility