Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008892509

FEI Number

3008892509

Entity Name

TECHNOMED ASIA, PT.

City/State/Country

Bandung Jawa Barat, ID

Establishment Address

K.I. Trikencana Kav. 4-5, Jl. Kopo Katapang km 11, Bandung Jawa Barat 40921, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Technomed Europe (Owner Number: 9036062)

Owner / Operator Contact Address

Wiebachstraat 25a, Kerkrade, NL-LI 6466NG, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Premium Neuro Single Kit Standard Neuro Single Kit Lantern Laryngeal Electrode Disposable Hypodermic Needle Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2001-11-15
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2008-01-02
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2026-03-17
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2026-03-17
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2020-04-24
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2008-01-02
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2008-01-02
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2024-12-17
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2024-12-17
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2008-01-02
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-01-03
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2008-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

Jennifer Maahs Business: Technomed USA, Inc. Email: orderustechnomed@welcony.com Phone: (651) 2880890

Related Public Records

Same Entity

Technomed Europe

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007389997	Technomed USA, Inc.	Roseville, MN, US
9710376	TECHNOMED EUROPE	Kerkrade Limburg, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

Similar Registrations

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3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3030387292	WISE S.p.A.	Cologno Monzese Lombardy, IT
3033919280	DONGGUAN GOOCHAIN TECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3017619000	SHENZHEN REDY-MED TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008892509. Last updated year: 2026. Please use registration number 3008892509 when referencing this establishment in official correspondence.