BEUDAMED
    FDA Registration Active 🇫🇷 France

    QUANTEL MEDICAL

    Reg #: 9680671 · FEI: 3003465293 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    QUANTEL MEDICAL
    Registration Number
    9680671
    FEI Number
    3003465293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 rue du bois Joli, CS40015
    City
    COURNON AUVERGNE Puy-de-Dome
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K130933

    Owner / Operator

    Firm Name
    QUANTEL MEDICAL
    Operator Number
    9002489
    Address
    1 Rue de Bois Joli, CS 40015
    City
    Cournon d’Auvergne, Cedex
    State
    FR-NOTA
    Postal Code
    63808
    Country
    FR
    Correspondent
    Bruno - Pages

    US Agent

    Business Name
    OConnell Regulatory Consultants, Inc.
    Contact Name
    Maureen OConnell
    Address
    44 Oak Street
    City
    Stoneham
    State
    MA
    ZIP
    02180
    Country
    US
    Email
    [email protected]
    Phone
    978 2071245

    Products

    Device Name Product Code
    Laser, Ophthalmic HQF
    Powered Laser Surgical Instrument GEX

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device