BEUDAMED
    FDA Registration Active 🇫🇷 France

    Syphilis Health Check

    Reg #: 3000254998 · FEI: 3000254998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VEDA LAB
    Registration Number
    3000254998
    FEI Number
    3000254998
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RUE DEL EXPANSION,, ZAT DU LONDEAU CERISE
    City
    ALENCON, CEDEX Orne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K102400

    Owner / Operator

    Firm Name
    VEDA LAB
    Operator Number
    9025559
    Address
    RUE DEL'EXPANSION,, ZAT DU LONDEAU CERISE
    City
    ALENCON, CEDEX
    State
    FR-NOTA
    Postal Code
    61006
    Country
    FR
    Correspondent
    Raphael - Donati

    US Agent

    Business Name
    Diagnostics Direct, LLC
    Contact Name
    Norman Proulx
    Address
    359 96th St Ste 303
    City
    Stone Harbor
    State
    NJ
    ZIP
    08247
    Country
    US
    Email
    [email protected]
    Phone
    609 3686912 ext. 102

    Products

    Device Name Product Code
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP

    Proprietary Names

    Syphilis Health Check

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)