BEUDAMED
    FDA Registration Active 🇫🇷 France

    NOVATECH S.A.

    Reg #: 9613846 · FEI: 3002807769 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    NOVATECH S.A.
    Registration Number
    9613846
    FEI Number
    3002807769
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1058, VOIE ANTIOPE, ZI ATHELIA 3
    City
    LA CIOTAT CEDEX Bouches-du-Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K971509

    Owner / Operator

    Firm Name
    NOVATECH SA
    Operator Number
    9011747
    Address
    VOIE ANTIOPE, ZI ATHELIA 3
    City
    LA CIOTAT CEDEX
    State
    FR-NOTA
    Postal Code
    13705
    Country
    FR
    Correspondent
    Marcus A Eisenhut

    US Agent

    Business Name
    Boston Medical Products, Inc.
    Contact Name
    Stuart Montgomery
    Address
    70 Chestnut St
    City
    Shrewsbury
    State
    MA
    ZIP
    01545
    Country
    US
    Email
    [email protected]
    Phone
    508 8989300

    Products

    Device Name Product Code
    Prosthesis, Tracheal, Preformed/Molded NWA
    Laparoscope, General & Plastic Surgery GCJ
    Catheters, Suction, Tracheobronchial BSY
    Bronchoscope (Flexible Or Rigid) EOQ
    Forceps, Ent KAE
    Instrument, Ent Manual Surgical LRC

    Proprietary Names

    TRACHEOBRONXANE-DUMON STENTS TalcAir Application System SURVAC DUTAU NOVATECH DUTAU Forceps ROTEPS TRACHEOBRONXANE™ DUMON® TONN TONN NOVATECH Stent Applicator

    Establishment Types

    Manufacture Medical Device