BEUDAMED
    FDA Registration Active 🇫🇷 France

    PLATINUM dRF

    Reg #: 9616491 · FEI: 3000255482 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    APELEM
    Registration Number
    9616491
    FEI Number
    3000255482
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Avenue du Canal Philippe LAMOUR
    City
    Gallargues-le-Montueux Gard
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K131766

    Owner / Operator

    Firm Name
    Apelem
    Operator Number
    10047281
    Address
    9 Avenue du Canal Philippe LAMOUR
    City
    Gallargues-le-Montueux
    State
    Gard
    Postal Code
    30660
    Country
    FR
    Correspondent
    Houda KACEM

    US Agent

    Business Name
    MEDIcept
    Contact Name
    F. David Rothkopf
    Address
    200 Homer Ave
    City
    Ashland
    State
    MA
    ZIP
    01721
    Country
    US
    Email
    [email protected]
    Phone
    617 8993449

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    PLATINUM dRF

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device