EUDAMED update: Jan 14, 2026

BioTeke Corporation（Wuxi）Co., Ltd

CN-MF-000007517

Active110 devices

Address: No. 90, Huiming Road, Huishan, Wuxi City, Jiangsu, 214000, 214000 Wuxi
Role: Manufacturer
Date of registration: Jun 15, 2021
Country: China

BioTeke Corporation（Wuxi）Co., Ltd is a medical device manufacturer registered in EUDAMED. The company has 110 devices on the EU market across 32 countries. It holds 4 valid CE certificates. Headquartered in Wuxi, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About BioTeke

: CN-MF-000007517
Role: Manufacturer
Country: China
Organization name: BioTeke Corporation（Wuxi）Co., Ltd
EU VAT number: 913202065617502076
Date of registration: Jun 15, 2021

Contact details for BioTeke

Phone: +86 （0510）8332 3992
Email: info@bioteke.cn
Website: www.bioteke.cn
Address: NO. 90, HUIMING ROAD, HUISHAN, WUXI CITY, JIANGSU, 214000, CHINA 214000 WUXI CHINA

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Competent authority

Name: Ministerie van Volksgezondheid, Welzijn en Sport

Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of BioTeke

ZHANG Guoqiang
Hidden

Connected operators

Importers

6 EU importers place this manufacturer's devices

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
Disposable sampling swab	Disposable sampling swab	`ST001-4`	`06974541564755`	1	On the market
Disposable sampling swab	Disposable sampling swab	`ST001-3`	`06974541564748`	1	On the market
Disposable sampling swab	Disposable sampling swab	`ST001-5`	`06974541564762`	1	On the market
Disposable sampling swab	Disposable sampling swab	`ST001-2`	`06974541564731`	1	On the market
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	`ICA2114-7`	`06974541564458`	5	On the market
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	`ICA2114-7`	`06974541564434`	1	On the market
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	`ICA2114-7`	`06974541564441`	2	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565714`	1	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565721`	2	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565745`	20	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565738`	5	On the market
ZK1500-4	—	`ZK1500-4`	`06974541564816`	1	On the market
ST9001-3	—	`ST9001-3`	`06974541564847`	1	On the market
PT10	—	`PT10`	`06974541565097`	1	On the market
AU18012-96	—	`AU18012-96`	`06974541564991`	1	On the market
ZK1500-5	—	`ZK1500-5`	`06974541564823`	1	On the market
ST8001-3	—	`ST8001-3`	`06974541564830`	1	On the market
BTK-E04-B1-40-00	—	`BTK-E04-B1-40-00`	`06974541565332`	1	On the market
ST7001-3	—	`ST7001-3`	`06974541563185`	1	On the market
ZK1000	—	`ZK1000`	`06974541565066`	1	On the market
AU18012	—	`AU18012`	`06974541564984`	1	On the market
ICA2114-7	—	`ICA2114-7`	`06974541564465`	20	On the market
ICA2230	—	`ICA2230`	`06974541565486`	1	On the market
ST001-1	—	`ST001-1`	`06974541564724`	1	On the market
DP4613	—	`DP4613`	`06974541564953`	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
Disposable sampling swab	Disposable sampling swab	`ST001-4`	`06974541564755`	1	On the market
Disposable sampling swab	Disposable sampling swab	`ST001-3`	`06974541564748`	1	On the market
Disposable sampling swab	Disposable sampling swab	`ST001-5`	`06974541564762`	1	On the market
Disposable sampling swab	Disposable sampling swab	`ST001-2`	`06974541564731`	1	On the market
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	`ICA2114-7`	`06974541564458`	5	On the market
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	`ICA2114-7`	`06974541564434`	1	On the market
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	`ICA2114-7`	`06974541564441`	2	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565714`	1	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565721`	2	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565745`	20	On the market
Saliva Pregnancy Test Kit	Saliva Pregnancy Test Kit	`ICA2235`	`06974541565738`	5	On the market
ZK1500-4	—	`ZK1500-4`	`06974541564816`	1	On the market
ST9001-3	—	`ST9001-3`	`06974541564847`	1	On the market
PT10	—	`PT10`	`06974541565097`	1	On the market
AU18012-96	—	`AU18012-96`	`06974541564991`	1	On the market
ZK1500-5	—	`ZK1500-5`	`06974541564823`	1	On the market
ST8001-3	—	`ST8001-3`	`06974541564830`	1	On the market
BTK-E04-B1-40-00	—	`BTK-E04-B1-40-00`	`06974541565332`	1	On the market
ST7001-3	—	`ST7001-3`	`06974541563185`	1	On the market
ZK1000	—	`ZK1000`	`06974541565066`	1	On the market
AU18012	—	`AU18012`	`06974541564984`	1	On the market
ICA2114-7	—	`ICA2114-7`	`06974541564465`	20	On the market
ICA2230	—	`ICA2230`	`06974541565486`	1	On the market
ST001-1	—	`ST001-1`	`06974541564724`	1	On the market
DP4613	—	`DP4613`	`06974541564953`	1	On the market

BioTeke Corporation（Wuxi）Co., Ltd

About BioTeke

Contact details for BioTeke

Export the 110 devices of BioTeke

Competent authority

Officers and regulatory representatives of BioTeke

Connected operators

Importers

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About BioTeke

Contact details for BioTeke

Export the 110 devices of BioTeke

Competent authority

Officers and regulatory representatives of BioTeke

Statistics for BioTeke

Certificate health for BioTeke

Related documents

Devices by risk class

Market presence of BioTeke

Device catalog for BioTeke

Device families (Basic UDI-DI) of BioTeke

Connected operators

Importers

Related searches

Statistics for BioTeke

Certificate health for BioTeke

Market presence of BioTeke

Devices by risk class

Related documents

Device catalog for BioTeke

Device families (Basic UDI-DI) of BioTeke