BEUDAMED
    FDA Registration Active 🇫🇷 France

    SEDATELEC

    Reg #: 8020802 · FEI: 5711 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SEDATELEC
    Registration Number
    8020802
    FEI Number
    5711
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CHEMIN DES MURIERS
    City
    IRIGNY Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K060392

    Owner / Operator

    Firm Name
    SEDATELEC
    Operator Number
    8020802
    Address
    CHEMIN DES MURIERS, --
    City
    IRIGNY
    State
    FR-NOTA
    Postal Code
    F-69540
    Country
    FR
    Correspondent
    HOUSSEM - BRAKNI

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Needle, Acupuncture, Single Use MQX
    Lamp, Infrared, Therapeutic Heating ILY
    Light, Examination, Medical, Battery Powered KYT
    Device, Pressure Applying KNM

    Proprietary Names

    ASP Titanium ASP Gold ASP Classic ASP Multi Gold ASP Multi Classic ASP Multi Titanium PREMIO 10 moxa EAR LIGHT D (ELD) Premio 40 - Light EASYO 6 Detector EASYO 1 - Multi Pressure Feeler EASYO 5 Detector EASYO 4 Detector EASYO 3 Detector EASYO 7 Detector EASYO 2 Detector PAL130 Pressure feeler 130g PAL400 Pressure feeler 400g BAT02 Glass rods PAL250 Pressure feeler 250g PAL650 Pressure feeler 650g EASYO 8 Detector

    Establishment Types

    Manufacture Medical Device