BEUDAMED
    FDA Registration Active 🇫🇷 France

    SDX System

    Reg #: 3008317830 · FEI: 3008317830 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DYN'R
    Registration Number
    3008317830
    FEI Number
    3008317830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1480 Avenue Armenie Pole Yvon Morandat
    City
    GARDANNE. Bouches-du-Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K942779

    Owner / Operator

    Firm Name
    Dyn'R
    Operator Number
    10031870
    Address
    1480 Avenue Armenie, Pole Yvon Morandat
    City
    Gardanne
    State
    Bouches-du-Rhone
    Postal Code
    13120
    Country
    FR
    Correspondent
    Gordon Fairbairn

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    SDX System

    Establishment Types

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