BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    ImmunoCard STAT! HpSA

    Reg #: 3007360698 · FEI: 3007360698 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OPERON, S.A.
    Registration Number
    3007360698
    FEI Number
    3007360698
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CAMINO DEL PLANO 19
    City
    CUARTE DE HUERVA Zaragoza
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K032222

    Owner / Operator

    Firm Name
    OPERON, S.A.
    Operator Number
    10027482
    Address
    CAMINO DEL PLANO 19
    City
    CUARTE DE HUERVA
    State
    Zaragoza
    Postal Code
    50410
    Country
    ES
    Correspondent
    DANIEL TORIBIO RENNER

    US Agent

    Business Name
    Meridian Bioscience
    Contact Name
    Susan Bogar
    Address
    3471 River Hills Drive
    City
    Cincinnati
    State
    OH
    ZIP
    45244
    Country
    US
    Email
    [email protected]
    Phone
    513 2713700 ext. 10124

    Products

    Device Name Product Code
    Helicobacter Pylori LYR

    Proprietary Names

    ImmunoCard STAT! HpSA

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)