BEUDAMED
    FDA Registration Active 🇹🇳 Tunisia

    Electrode, electrocardiograph

    Reg #: 3031754347 · FEI: 3031754347 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Plastic Electromechanic Company MEDICAL DEVICE
    Registration Number
    3031754347
    FEI Number
    3031754347
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Z.I 3 Djebel Oust BP 14 Bir Mcherga 1141 ZAGHOUAN TUNISIE (PECMED), PEC MED
    City
    Bir Mcherga Zaghouan
    Country
    TN

    Regulatory Submissions

    510(k) Number
    K101685

    Owner / Operator

    Firm Name
    PLastic Electromechanic company PLUS
    Operator Number
    10058990
    Address
    32, 33 ZI Hammam Zriba BP34 1152
    City
    Hammam Zriba
    State
    Zaghouan
    Postal Code
    1152
    Country
    TN
    Correspondent
    Slim Jebri

    US Agent

    Business Name
    GRAPHIC CONTROLS d.b.a Nissha Medical Technologies
    Contact Name
    Jessica Potter
    Address
    400 Exchange St
    City
    Buffalo
    State
    NY
    ZIP
    14204
    Country
    US
    Email
    [email protected]
    Phone
    716 8496367

    Products

    Device Name Product Code
    Electrode, Electrocardiograph DRX

    Proprietary Names

    Electrode, electrocardiograph

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)