BEUDAMED
    FDA Registration Active 🇫🇷 France

    NephroCheck Test System

    Reg #: 8020790 · FEI: 1000611339 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOMERIEUX SA
    Registration Number
    8020790
    FEI Number
    1000611339
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CHEMIN DE L ORME
    City
    MARCY L ETOILE Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K171482

    Owner / Operator

    Firm Name
    BIOMERIEUX SA
    Operator Number
    8020790
    Address
    Chemin De L Orme
    City
    Marcy L Etoile
    State
    Rhone
    Postal Code
    69280
    Country
    FR

    US Agent

    Business Name
    BioMerieux, SA
    Contact Name
    Nathan Hardesty
    Address
    595 Anglum Rd, Bldg. 1, 2nd Flr.
    City
    Hazelwood
    State
    MO
    ZIP
    63042
    Country
    US
    Email
    [email protected]
    Phone
    314 7318666

    Products

    Device Name Product Code
    Acute Kidney Injury Test System PIG

    Proprietary Names

    NephroCheck Test System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility