Stimulator, Auditory, Evoked Response

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Shaanxi: 4 hold an FDA registration. 3 are contract manufacturers.

Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
Dong Guan Danchen Electrical Products Ltd. Guangdong, contract manufacturer
GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer
Xian Friendship Medical Electronics Co., Ltd. Shaanxi, contract manufacturer

What Is FDA Product Code GWJ?

Stimulator, Auditory, Evoked Response is FDA product code GWJ, Class 2, 21 CFR 882.1900.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Device Design (2), PMA (1) and Component change control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Stimulator, Auditory, Evoked Response

1077 Eartip 6-9MM Blue 100 PCS

Catalogue number 8-68-34504, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip Soft ET-16 Pack/100 Pcs.

Catalogue number 100838-100, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

1077 Eartip 9-13 Foam 250 PCS

Catalogue number 8-68-32809, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip ET-S11 Pack/250 Pcs.

Catalogue number 100840-250, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Screener Cart

Catalogue number M998920, listed by Intelligent Hearing Systems Corp., United States, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

VivoTab Electrode (3 Pack)

Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 00627908080011respectively). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

Stimulator, Auditory, Evoked Response

1077 Eartip 8-11 Trans 50 PCS

Catalogue number 8-68-32806, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Aurix Laptop Computer

Laptop computer for use with Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Stimulator, Auditory, Evoked Response

ABR Desktop Stand/Crib Carry Crib

Catalogue number ABR-DS, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Stimulator, Auditory, Evoked Response

Cord 945CPC16 Hosp Grade Line

Stimulator, Auditory, Evoked Response

Otocheck – ABR Screener

Catalogue number OC-ABR, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Carescape

Carescape 19 Inch Display D19KT

Stimulator, Auditory, Evoked Response

Ear Tip ET-20 Pack/250 Pcs.

Catalogue number 100576-250, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip ET-14 Pack/250 Pcs.

Catalogue number 100230-250, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip Soft ET-LT10F Pack/100 Pcs.

Catalogue number 101035-100, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

1077 Eartip 12-16 Blue 250 PCS

Catalogue number 8-68-32805, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

ABR Fixing Screw

Catalogue number ABR-SCR, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Algo Newborn Hearing Screener

The ALGO 5 Newborn Hearing Screener is a mobile, cart-based, noninvasive instrument used to screen infants for hearing loss.

Stimulator, Auditory, Evoked Response

Ear Tip ET-15 Pack/50 Pcs.

Catalogue number 100699-50, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Probe Tip PT-LT 10pack

Catalogue number 101014-10, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

1077 Accessory Box AB07

Accessory box Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Probe Tip 'Adult' for Children & Adults. AN100013 3. Ear tip ET-03 5 mm. AN100063 4. Ear tip Lamella 6-10mm,…

Stimulator, Auditory, Evoked Response

Ear Tip PM018H Pack/100 Pcs.

18 mm mushroom ear tip, hard version

Stimulator, Auditory, Evoked Response

Sentiero Basic AuDX Set

Basic Set for AuDX branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX A/N100098-AU - Headphone HB7/DD45 A/N100306-US - Probe EP-DP PATH long A/N100028-US - FW…

Stimulator, Auditory, Evoked Response

QScreen

The FDA filing identifies QScreen, device code PM1610, as a handheld portable hearing screener. It records and automatically evaluates otoacoustic emissions and auditory brainstem…

Stimulator, Auditory, Evoked Response

1077 Eartip 8-11 Trans 100 PCS

Catalogue number 8-68-34510, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip Soft ET-17 Pack/250 Pcs.

Catalogue number 100839-250, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip ET-LT35 Pack/100 Pcs.

Catalogue number 101037-100, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Aurix Insert Earphones

ER-3A insert earphones for use as an accessory with the Aurix system (DI: 00627908080011) The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) +…

Stimulator, Auditory, Evoked Response

1077 Eartip 12-16 Blue 100 PCS

Catalogue number 8-68-34507, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip Soft ET-16 Pack/50 Pcs.

Catalogue number 100838-50, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Algo 7i Patient Cable Long

ALGO 7i Patient Cable 72 Inch

Stimulator, Auditory, Evoked Response

EarHug

A pair of EarHugs

Stimulator, Auditory, Evoked Response

Headphone DD-45

DD-45 headphone with HB-7 headband

Stimulator, Auditory, Evoked Response

SEP StartUp Kit – 1 Channel

Catalogue number M019200, listed by Intelligent Hearing Systems Corp., United States, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

BGS Body & Lid for UGS ECP and SGS Probe

BGS Body & Lid for UGS ECP and SGS probe: 1 catalogue number listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Aurix Amplifier

Amplifier for use with the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Stimulator, Auditory, Evoked Response

BrainView NeuralScan

Catalogue number HW9N, listed by Medeia Group Ltd, Bulgaria, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip ET-15 Pack/250 Pcs.

Catalogue number 100699-250, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Duet Plug Lead StartUp Kit

Catalogue number M019209, listed by Intelligent Hearing Systems Corp., United States, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Aurix Newborn Hearing Screening System

Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following devices…

Stimulator, Auditory, Evoked Response

Ear Tip PM008 Pack/100 Pcs. (Grason)

Catalogue number 100766-100, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Otoport/Otocheck Carry Case With Printer

Catalogue number OPP-CAS, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Otocheck – Dpoae + ABR Screener

Catalogue number OC-SD+ABR, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Probe EP-LT (QScreen)

EP-LT ear probe, red connector, 2 mics

Stimulator, Auditory, Evoked Response

Ear Tip IT-03 Pack/250 Pcs.

Catalogue number 100840-250, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip PM010H Pack/100 Pcs.

10 mm mushroom ear tip, hard version

Stimulator, Auditory, Evoked Response

Algo 7i Set 1

ALGO 7i Base Kit containing: 1x 101049 ALGO 7i 1x 101121 ALGO7i Multidata Cable 1x 100524 Power Supply 1x 100525-EU Power Supply Adapter EU 1x 100525-US Power Supply Adapter US 1x 100525-UK…

Stimulator, Auditory, Evoked Response

Ear Coupler Set

Ear Coupler Set (25 pcs.)

Stimulator, Auditory, Evoked Response

Ear Tip ET-10 Pack/50 Pcs.

Catalogue number 100064-50, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Foam Small Teoae Probe Tips

Catalogue number T-T200S, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Electrode Cable 1m

Catalogue number ABR-EC1, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

NeMus 2 600

EEG/EMG/EP System

Stimulator, Auditory, Evoked Response

Bio-Logic

The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible…

Stimulator, Auditory, Evoked Response

USBLite Solo

Catalogue number M011140, listed by Intelligent Hearing Systems Corp., United States, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Ear Tip ET-S03 Pack/250 Pcs.

Catalogue number 100031-250, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Electrode Cable 2m

Catalogue number ABR-EC2, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

1077 Eartip 5MM Blue 100 PCS

Catalogue number 8-68-34501, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Accessory Box AB-LT02

Accessory Set, consisting of: 1x 100336 [Box] 1x 101315-E [QScreen Check Kit] 5x 101014 [Probe Tip LT Probe] 3x 100186 [Acoustic Filter] 5x 100151 [Cleaning Tool CT-01] 10x 101035 [Foam Tip…

Stimulator, Auditory, Evoked Response

Ear Tip ET-S01 Pack/100 Pcs.

Catalogue number 100029-100, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Evoke EEG System Amplifier

The Evoke EEG System Amplifier is intended to increase signal levels during the acquisition of electrical activity of a patient’s brain.

Stimulator, Auditory, Evoked Response

Aurix Sound Stimulator

Sound stimulator for use with the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Stimulator, Auditory, Evoked Response

Ear Tip PM009 Pack/100 Pcs.

9 mm mushroom ear tip

Stimulator, Auditory, Evoked Response

Ear Tip ET-LT60M Pack/100 Pcs.

Catalogue number 101368-100, listed by Path, Germany, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

Accessory Box AB05

Accessory box Sentiero Screening Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Ear tip ET-03 5 mm. AN100063 3. Ear tip Lamella 6-10mm, blue AN100064 4. Ear Tip, Lamella…

Stimulator, Auditory, Evoked Response

DPC Couplers Couplers

Catalogue number DPC-100, listed by Otodynamics, Ltd., United Kingdom, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Stimulator, Auditory, Evoked Response

SmartScreener-Plus2 Screener Launch

Catalogue number M812002, listed by Intelligent Hearing Systems Corp., United States, under Stimulator, Auditory, Evoked Response. 4 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer