BEUDAMED
    FDA Registration Active 🇫🇷 France

    QUALIFORMED SAS

    Reg #: 3009607881 · FEI: 3009607881 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    QUALIFORMED SAS
    Registration Number
    3009607881
    FEI Number
    3009607881
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    19 impasse de La Boetie
    City
    La Roche Sur Yon Pays de la Loire
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K172534

    Owner / Operator

    Firm Name
    QualiFormeD SAS
    Operator Number
    10040700
    Address
    19 impasse de La Boetie
    City
    La Roche Sur Yon
    State
    Pays de la Loire
    Postal Code
    85000
    Country
    FR
    Correspondent
    Stephane Beaumont

    US Agent

    Business Name
    Speed To Market, Inc.
    Contact Name
    Maren Kroenke
    Address
    10 Evergreen Way
    City
    Nederland
    State
    CO
    ZIP
    80466
    Country
    US
    Email
    [email protected]
    Phone
    303 9564233

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    Test-Pattern, Radiographic IXF
    Instrument, Quality-Assurance, Radiologic LHO
    Phantom, Anthropomorphic, Radiographic IXG

    Proprietary Names

    LINACWATCH OTP-FIELD OTP-LAS OTP-CROSS-KV2-VA OTP-PLATE-EL OTP-TOMOT-SR OTP-ABACUS-CL OTP-ALIGN OTP-PLAN OTP-FIELD-STICKER OTP-CROSS-MV OTP-ABACUS-EL OTP-FIELD28 OTP-BALL OTP-CROSS OTP-EPID-L OTP-ISO+ OTP-DISTO OTP-PLATE-VA OTP-TOMOT-ST OTP-EPID OTP-CROSS-KV2-EL OTP-FIELD03 OTP-FIELD18 OTP-FIELD08 MAGICTAPE FIELD-TAPE OTP-FIELD01 QUALIMAGIQ DIGIBOX QUALINAX DIGIPHAN

    Establishment Types

    Manufacture Medical Device