BEUDAMED
    FDA Registration Active 🇫🇷 France

    HELIO DIAGNOSTICS SAS

    Reg #: 3039487170 · FEI: 3039487170 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    HELIO DIAGNOSTICS SAS
    Registration Number
    3039487170
    FEI Number
    3039487170
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    163 avenue de Luminy
    City
    Marseille Bouches-du-Rhone
    Country
    FR

    Owner / Operator

    Firm Name
    Helio Diagnostics SAS
    Operator Number
    10093994
    Address
    163 avenue de Luminy
    City
    Marseille
    State
    Bouches-du-Rhone
    Postal Code
    13009
    Country
    FR
    Correspondent
    Fabienne Hermitte

    US Agent

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

    Products

    Device Name Product Code
    Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer NYI

    Proprietary Names

    Prosigna Breast Cancer Assay

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)