BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    Disposable XS Subdermal Needle Electrode

    Reg #: 3008892509 · FEI: 3008892509 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TECHNOMED ASIA, PT.
    Registration Number
    3008892509
    FEI Number
    3008892509
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    K.I. Trikencana Kav. 4-5, Jl. Kopo Katapang km 11
    City
    Bandung Jawa Barat
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K130136

    Owner / Operator

    Firm Name
    Technomed Europe
    Operator Number
    9036062
    Address
    Wiebachstraat 25a
    City
    Kerkrade
    State
    Limburg
    Postal Code
    6466NG
    Country
    NL

    US Agent

    Business Name
    Technomed USA, Inc.
    Contact Name
    Jennifer Maahs
    Address
    1626 Terrace Dr., Roseville
    City
    Minneapolis
    State
    MN
    ZIP
    55413
    Country
    US
    Email
    [email protected]
    Phone
    651 2880890

    Products

    Device Name Product Code
    Electrode, Needle GXZ
    Electrode, Needle, Diagnostic Electromyograph IKT

    Proprietary Names

    Disposable XS Subdermal Needle Electrode Disposable Subdermal Needle Electrode, XS Disposable Monopolar Needle Electrode Disposable Subdermal Needle Electrode, parallel Disposable Monopolar Needle Electrode, detachable, trocar tip Disposable Monopolar Needle Electrode, pre-wired, trocar tip Disposable Subdermal Needle Electrode, twisted Disposable Subdermal Needle Electrode, hooked Disposable Subdermal Needle Electrode, curved Disposable Monopolar Needle Electrode, pre-wired, pencil tip Disposable Subdermal Needle Electrode Disposable Subdermal Needle Electrode, Pt/Ir Disposable Subdermal Needle Electrode, corkscrew Disposable Monopolar Needle Electrode, detachable, pencil tip Disposable Subdermal Needle Electrode, corkscrew, twisted

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)