BEUDAMED
    FDA Registration Active 🇫🇷 France

    MAUNA KEA TECHNOLOGIES

    Reg #: 3004542960 · FEI: 3004542960 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MAUNA KEA TECHNOLOGIES
    Registration Number
    3004542960
    FEI Number
    3004542960
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9, RUE D ENGHIEN
    City
    PARIS Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K172844

    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
    Confocal Optical Imaging OWN
    Laparoscope, General & Plastic Surgery GCJ
    Endoscope, Neurological GWG

    Proprietary Names

    Cellvizio 100 Series Systems with Confocal Miniprobes Cellvizio 100 Series with Confocal Miniprobes CelioFlex™ UHD 5 UROFLEX B CYSTOFLEX F GastroFlex M Confocal Miniprobe Cellvizio 100 Series Cellvizio 100 Series System with Confocal Miniprobes AlveoFlex M Confocal Miniprobe CranioFlex™ CranioFlex™-C UroFlex™ B-C CystoFlex™ F-C AQ-Flex™ 19 -C CholangioFlex™ -C Cellvizio® 100 Series with Confocal Miniprobes¿ Cellvizio® I.V.E. System with Confocal Miniprobes™ Cellvizio 100 Series¿ CystoFlex™ UHD R-C CelioFlex™UHD 5-C CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) CelioFlex UHD Confocal Miniprobes to be used with Cellvizio 100 Series Systems CystoFlex UHD R

    Establishment Types

    Manufacture Medical Device