EUDAMED update: Aug 17, 2026

AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

CN-MF-000017842

Active61 devices

Address: Wengjiao West Road, Haicang District, Ground Floor and Third Floor, Building No.B8, Biomedical Industrial Park, No.2064 361022 Xiamen
Role: Manufacturer
Date of registration: Dec 9, 2021
Country: China

AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD. is a medical device manufacturer registered in EUDAMED. The company has 61 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in Xiamen, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

: CN-MF-000017842
Role: Manufacturer
Country: China
Organization name: AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.
EU VAT number: Not applicable
Trade register: 91350200612051175K
Date of registration: Dec 9, 2021

Contact details for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Phone: +86 592 5971216
Email: yangyiqun@austar-hearing.com
Website: www.austar-hearing.net
Address: GROUND FLOOR AND THIRD FLOOR, BUILDING NO.B8, BIOMEDICAL INDUSTRIAL PARK, NO.2064, WENGJIAO WEST ROAD, HAICANG DISTRICT XIAMEN CITY ,FUJIAN, CHINA 361022 XIAMEN CHINA

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Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Officers and regulatory representatives of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

YANG Ula
(a) the conformity of the devices is in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the TD and the EU DOC are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with <Post Market Surveillance Procedure>; (d) the reporting obligations referred to in <Vigilance System Control Procedure> are fulfilled. (e) investigational devices, see Chapter II of Annex XV.
Hidden
WU Kylin
(a) the conformity of the devices is in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the TD and the EU DOC are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with <Post Market Surveillance Procedure>; (d) the reporting obligations referred to in <Vigilance System Control Procedure> are fulfilled. (e) investigational devices, see Chapter II of Annex XV.
Hidden

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Austar	Austar	`D-C-E3B`	`06943786004210`	1	On the market
Austar	Austar	`J306`	`06943786001028`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J708P`	`06943786001806`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`BL16R`	`06943786000762`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`DE08P`	`06943786001738`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J906`	`06943786001059`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J706P`	`06943786001264`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L808P`	`06943786001837`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J506`	`06943786001035`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J506P`	`06943786001257`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J508P`	`06943786001790`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J308P`	`06943786001783`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J306P`	`06943786001240`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`DM08P`	`06943786001752`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J906P`	`06943786001271`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`EP06`	`06943786001110`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J706`	`06943786001042`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L408P`	`06943786001820`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L406P`	`06943786001288`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`PP13A`	`06943786000052`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`LS08P`	`06943786001844`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L806P`	`06943786001295`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J908P`	`06943786001813`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`STD13A`	`06943786000021`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`RS13A`	`06943786000045`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Austar	Austar	`D-C-E3B`	`06943786004210`	1	On the market
Austar	Austar	`J306`	`06943786001028`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J708P`	`06943786001806`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`BL16R`	`06943786000762`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`DE08P`	`06943786001738`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J906`	`06943786001059`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J706P`	`06943786001264`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L808P`	`06943786001837`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J506`	`06943786001035`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J506P`	`06943786001257`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J508P`	`06943786001790`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J308P`	`06943786001783`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J306P`	`06943786001240`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`DM08P`	`06943786001752`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J906P`	`06943786001271`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`EP06`	`06943786001110`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J706`	`06943786001042`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L408P`	`06943786001820`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L406P`	`06943786001288`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`PP13A`	`06943786000052`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`LS08P`	`06943786001844`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`L806P`	`06943786001295`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`J908P`	`06943786001813`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`STD13A`	`06943786000021`	1	On the market
BTE Hearing Aids	BTE Hearing Aids	`RS13A`	`06943786000045`	1	On the market

AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

About AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Contact details for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Export the 61 devices of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Competent authority

Officers and regulatory representatives of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Related searches

About AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Contact details for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Export the 61 devices of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Competent authority

Officers and regulatory representatives of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Statistics for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Certificate health for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Related documents

Devices by risk class

Market presence of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Device catalog for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Device families (Basic UDI-DI) of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Related searches

Market presence of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Devices by risk class

Statistics for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Certificate health for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Related documents

Device catalog for AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.

Device families (Basic UDI-DI) of AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.