BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Assut Europe S.P.A.

    Reg #: 9617547 · FEI: 3003272809 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Assut Europe S.P.A.
    Registration Number
    9617547
    FEI Number
    3003272809
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zona Industriale
    City
    Magliano Dei Marsi L'Aquila
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K150553

    Owner / Operator

    Firm Name
    ASSUT EUROPE S.P.A.
    Operator Number
    9044488
    Address
    VIA G. GREGORACI, 12
    City
    Roma
    State
    IT-RM
    Postal Code
    00173
    Country
    IT

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Endoscopic Tissue Approximation Device OCW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

    Proprietary Names

    Assufil Monofilamento Filbloc E-LOC Endo360 suture THD Block US E-LOC non absorbable Endo360, barbed suture Filbloc Permanent Assut Fibloc Permanent Sutures SutureTOOL System Appolo Endosurgery 2-0 Polypropylene Suture (PLY-G02-020-APL) ASSUFIL

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)