BEUDAMED
    FDA Registration Active 🇫🇷 France

    CranioFlex™

    Reg #: 3004542960 · FEI: 3004542960 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MAUNA KEA TECHNOLOGIES
    Registration Number
    3004542960
    FEI Number
    3004542960
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9, RUE D ENGHIEN
    City
    PARIS Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K180270

    Owner / Operator

    Firm Name
    Mauna Kea Technologies
    Operator Number
    9074201
    Address
    9, RUE D'ENGHIEN, --
    City
    PARIS
    State
    Ile-de-France
    Postal Code
    F-75010
    Country
    FR
    Correspondent
    Emmanuel - Prades

    Products

    Device Name Product Code
    Endoscope, Neurological GWG
    Confocal Optical Imaging OWN

    Proprietary Names

    CranioFlex™ CranioFlex™-C

    Establishment Types

    Manufacture Medical Device