BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    AbioSCOPE, IVD CAPSULE PSP

    Reg #: 3013960814 · FEI: 3013960814 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ABIONIC SA
    Registration Number
    3013960814
    FEI Number
    3013960814
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Biopole, Building Alanine, Route de la Corniche 5
    City
    Epalinges Vaud
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K240041

    Owner / Operator

    Firm Name
    Abionic SA
    Operator Number
    10055862
    Address
    Biopole, Alanine Building, Route de la Corniche 5
    City
    Epalinges
    State
    CH-NOTA
    Postal Code
    CH-1066
    Country
    CH

    Products

    Device Name Product Code
    Immunoassay For Host Biomarkers Of Sepsis SCX

    Proprietary Names

    AbioSCOPE, IVD CAPSULE PSP

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device