BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    FlexLab, several models

    Reg #: 3005509212 · FEI: 3005509212 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    INPECO S.P.A.
    Registration Number
    3005509212
    FEI Number
    3005509212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Givoletto 15
    City
    Val della Torre Torino
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K121012

    Owner / Operator

    Firm Name
    INPECO S.p.A.
    Operator Number
    9100479
    Address
    via Givoletto 15
    City
    Val della Torre
    State
    Torino
    Postal Code
    10040
    Country
    IT
    Correspondent
    Emanuele - Bugnone

    US Agent

    Business Name
    THEMA CORP
    Contact Name
    Silvia Tamarri
    Address
    2929 Arch Street
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US
    Email
    [email protected]
    Phone
    215 8459459

    Products

    Device Name Product Code
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Calculator/Data Processing Module, For Clinical Use JQP
    Electrode, Ion Specific, Sodium JGS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    FlexLab, several models Aptio Automation ACCELERATOR a3600

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)