BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Tutogen Medical GmBH

    Reg #: 3002924436 · FEI: 3002924436 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Tutogen Medical GmBH
    Registration Number
    3002924436
    FEI Number
    3002924436
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Industriestrasse 6
    City
    Neunkirchen am Brand Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K123356

    Owner / Operator

    Firm Name
    RTI Surgical, Inc. (dba RTI Biologics, Inc.)
    Operator Number
    1641375
    Address
    11621 Research Circle
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    Rosanne Lopez

    Products

    Device Name Product Code
    Mesh, Surgical FTM
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Dura Substitute GXQ
    Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery OXF
    Barrier, Animal Source, Intraoral NPL

    Proprietary Names

    Fortiva¿ porcine dermis, Tutoplast® porcine dermis Tutomesh® Bovine Pericardium Tutopatch® Bovine Pericardium Tutopatch DM Graft Tutoplast Bovine Pericardium DM Bovine Pericardium Suturable Dural Graft Fortiva Porcine Dermis Bovine Pericardium Tutodent® membrane CopiOs® Pericardium Membrane

    Establishment Types

    Manufacture Medical Device