BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    TECHNOMED ASIA, PT.

    Reg #: 3008892509 · FEI: 3008892509 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    69
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    TECHNOMED ASIA, PT.
    Registration Number
    3008892509
    FEI Number
    3008892509
    Status
    Active
    Expiry Year
    2026
    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
    K241045

    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
    City
    Roseville
    State
    MN
    ZIP
    55113
    Country
    US
    Email
    [email protected]
    Phone
    651 2880890

    Products

    Device Name Product Code
    Cable, Electrode IKD
    Electrode, Cutaneous GXY
    Electrode, Needle, Diagnostic Electromyograph IKT
    Electrode, Needle GXZ
    Stimulator, Nerve, Peripheral, Electric KOI
    Stimulator, Nerve ETN

    Proprietary Names

    Reusable Shielded Cable Reusable Unshielded Cable Disposable Stimulation Clip Stimulation Clip Reusable Unshielded Cable for detachable monopolar EMG needle electrode Reusable Shielded Cable for detachable monopolar EMG needle electrode Reusable Shielded Cable for concentric + single fiber EMG needle electrode Premium Neuro Single Kit Extension cable DIN male to female Standard Neuro Single Kit Reusable Ear Clip Electrode Disposable EEG Cup Electrode Ag/AgCl coated Reusable Ear clip Electrode Ag plated Reusable EEG Cup Electrode Ag plated Reusable Ear clip Electrode Au plated Reusable EEG Cup Electrode Au plated Disposable EEG XS Cup Electrode Ag/Agcl coated Disposable EEG Cup Electrode Reusable EEG Cup Electrode Reusable EEG Cup Electrode Ag/AgCl coated Reusable Ear clip Electrode Ag/AgCl coated Disposable EEG Cup+ Electrode Disposable EEG Cup+ Electrode Ag/AgCl coated Disposable EEG XS Cup Electrode TetraSens Disposable Concentric Needle Electrode Pt/Ir electrode, Gold plated needle Reusable Concentric Needle Electrode Disposable Concentric Needle Electrode Reusable Subdermal Needle Electrode Disposable Subdermal Needle Electrode, Pt/Ir Disposable Subdermal Needle Electrode, corkscrew, twisted Disposable Subdermal Needle Electrode, corkscrew Disposable Stimulation Probe Disposable Ball Tip Probe Disposable XL Pedicle Screw Probe Disposable Pedicle Screw Probe Lantern Laryngeal Electrode Disposable Hypodermic Needle Electrode Disposable Monopolar Needle Electrode, detachable, trocar tip Disposable Monopolar Needle Electrode, detachable, pencil tip Disposable Subdermal Needle Electrode Disposable Monopolar Needle Electrode, pre-wired, trocar tip Disposable Subdermal Needle Electrode, XS Disposable Subdermal Needle Electrode, hooked Disposable Monopolar Needle Electrode Disposable Subdermal Needle Electrode, curved Disposable Subdermal Needle Electrode, twisted Disposable Monopolar Needle Electrode, pre-wired, pencil tip Disposable Subdermal Needle Electrode, parallel Disposable XS Subdermal Needle Electrode Disposable Stimulating Curved Needle Disposable Surgical Instrument Disposable Stimulating Ring Dissector Disposable Stimulating Dissectors Disposable Stimulating Elevators Disposable Adhesive Surface Electrode Disposable NCV Electrode kit Disposable Adhesive Surface Electrode, twisted Disposable Adhesive Surface Electrode, ground Disposable Adhesive Ground Electrodes Disposable Adhesive 4-Disk Electrodes Disposable Stimulation Probe Disposable Bipolar Probe, twisted Disposable Triple Hooked Probe Disposable Monopolar Probe Disposable Concentric Probe Disposable Stimulation Probe Disposable Concentric Probe, twisted Disposable Double Hooked Probe Disposable Bipolar Probe Disposable Stimulation Probe Disposable XL Monopolar Probe Disposable Stimulation Probe Disposable Monopolar Probe

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device