BEUDAMED
    FDA Registration Active 🇫🇷 France

    OLEA MEDICAL

    Reg #: 3007675959 · FEI: 3007675959 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    OLEA MEDICAL
    Registration Number
    3007675959
    FEI Number
    3007675959
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    93 Avenue du Sorbier, Zone Athelia IV
    City
    La Ciotat Bouches-du-Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K223502

    Owner / Operator

    Firm Name
    Olea Medical S.A.S.
    Operator Number
    10028761
    Address
    93 Avenue du Sorbier, Zone Athelia IV
    City
    La Ciotat
    State
    Bouches-du-Rhone
    Postal Code
    13600
    Country
    FR

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    System, Digital Image Communications, Radiological LMD
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    MR Diffusion Perfusion Mismatch V1 Neurovascular Insight V1 MR DWI/FLAIR Measurement V1 Neuro Insight V1 Automation Platform V3 Olea S.I.A V1 Automation Platform V1.5 Automation Platform V3.1 OLEA SPHERE V3 CT Perfusion V1 breastscape V1 Functional MR V1

    Establishment Types

    Manufacture Medical Device