Data / Medical devices / Indonesia / Technomed Asia, PT.

Technomed Asia, PT.: FDA-registered device maker in Bandung Jawa Barat, Indonesia, 1 510(k) clearance

Name: Technomed Asia, PT. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Technomed Asia, PT. is registered with the FDA (registration 3008892509) in Bandung Jawa Barat, Indonesia. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 11, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008892509
Address: K.I. Trikencana Kav. 4-5 Jl. Kopo Katapang km 11, Bandung Jawa Barat, Indonesia, 40921
Owner or operator: Technomed Europe (9036062)
Roles: Contract manufacturer, Manufacturer
First device listed: November 15, 2001
Registered through: 2026
Brand names listed: Disposable Adhesive 4-Disk Electrodes, Disposable Adhesive Ground Electrodes, Disposable Adhesive Surface Electrode, Disposable Adhesive Surface Electrode, ground, Disposable Adhesive Surface Electrode, twisted, Disposable Bipolar Probe, Disposable Concentric Needle Electrode, Disposable Concentric Needle Electrode Pt/Ir electrode, Gold plated needle and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Contract manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer	accessdata.fda.gov
Electrode, Needle	GXZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Needle, Diagnostic Electromyograph	IKT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 11, 2024	K241045	Disposable Subdermal Needle Electrode, Corkscrew	GXZ	Substantially Equivalent	Technomed Europe	accessdata.fda.gov

Compare with other makers

Updated December 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.