Our offers

Solutions by role

QARA & regulatory affairsbuild your profile page
Manufacturersenrich your page for free

Features & tools

HTTP APIto embed the medical-device market in your tools
DataVizspot the trends at a glance
MCP serverThe medical-device market, inside your AI assistant
Monitoring & alertsof MedTech companies
Data exportsof your search results
Data enrichmentof all your company dataContact us
CRMto enrich your recordsContact us
DataMatrix generationcompliant DataMatrix generation
UDI scanningidentify medical devices by scanning them
Compliance supportsupport for your regulatory needsContact us
Commercial intelligencespot commercial opportunitiesContact us
Company mappingthe relationship graph of companiesContact us
Featured placementat the top of search results

PricingAll featuresContact us

Pricing Sign in

Role
Country
Date of registration
Address

© 2026 Made In Tracker

Explore

Companies Devices Documents Persons

Resources

Blog FAQ Glossary About Features

Company

Pricing Partners Refer & earn Top referrers Contact

Legal

Privacy Policy Legal Notice

Ecosystem

Made In Tracker (opens in new tab)EasyUDI (opens in new tab)

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Monthly EUDAMED change digest

Get a monthly digest of the new devices, certificates and manufacturers added to EUDAMED — straight to your inbox.

By subscribing, you accept the General Personal Data Protection Policy.Check the consent box to subscribe.

BioTeke Corporation（Wuxi）Co., Ltd — Manufacturer in China

EUDAMED update: Jan 14, 2026

BC

BioTeke Corporation（Wuxi）Co., Ltd

China

All roles followed

Views by role

Sources: EUDAMED

Legal information of BioTeke

Legal name: BioTeke Corporation（Wuxi）Co., Ltd
EU VAT number: 913202065617502076
SRN (displayed role): CN-MF-000007517
EUDAMED status: Active· registered in 2021
Registered office: No. 90, Huiming Road, Huishan, Wuxi City, Jiangsu, 214000, 214000 Wuxi, China

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

Data export

Export the 110 devices of BioTeke

Get the catalogue in Excel or CSV format — trade name, product reference, UDI and EMDN codes, legislation, quantity, last update, and more. The exact row count and price are confirmed before you pay.

Export results

Applied filters

SRNCN-MF-000007517

Format

Summary

32 columns included

Need whole-dataset or bulk access? Contact us

Learn more about exports

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In TrackerBecome a partner of MD Atlas

Related searches

Medical device manufacturers in EUDAMED

Competent authority for BioTeke

Ministerie van Volksgezondheid, Welzijn en Sport
NetherlandsContact the authority →

Related documents of BioTeke

Technical documentation

Certificate EU-TDA-FI-43117-800031-2025Rev. 3

Issued

Manufacturer

BioTeke Corporation（Wuxi）Co., Ltd

Notified body

Sertio Oy

3018

Version

1

Valid from

7/9/2026

Valid until

5/30/2030

Quality management system

Certificate EU-QMS-FI-40845-800031-2025Rev. 2

Issued

Manufacturer

BioTeke Corporation（Wuxi）Co., Ltd

Notified body

Sertio Oy

3018

Version

1

Valid from

7/9/2026

Valid until

5/30/2030

Quality management system

Certificate EU-QMS-FI-40845-800031-2025

Issued

Manufacturer

BioTeke Corporation（Wuxi）Co., Ltd

Notified body

Sertio Oy

3018

Version

1

Valid from

5/30/2025

Valid until

5/30/2030

Technical documentation

Certificate EU-TDA-FI-43117-800031-2025Rev. 1

Issued

Manufacturer

BioTeke Corporation（Wuxi）Co., Ltd

Notified body

Sertio Oy

3018

Version

1

Valid from

5/30/2025

Valid until

5/30/2030

Market presence of BioTeke

Devices placed in 32 countries

Risk categories of BioTeke

Executives & regulatory representatives of BioTeke

2 contacts identified

PRRC
ZHANG Guoqiang
Hidden

View profile →

110Total Devices

43Basic UDI-DIs

4Certificates4 valid · 0 expiring < 12 months

32CountriesEU/EEA placements

Certificates of BioTeke

Cartography of BioTeke

Authorised representativeNotified bodiesPeople

Sertio Oy — 4 certificates — BioTeke
SUNGO Europe B.V. — represents — BioTeke
Medunion S.L. — represents — BioTeke
ZHANG Guoqiang — BioTeke

Catalog of BioTeke

110 devices · 43 families

Filter

Disposable Sterile Sampling SwabSS001-1, SS001-2, SS001-3, SS001-4, SS001-5, SS001-6, SS001-77 versions
Nucleic Acid Extraction KitDP4611,DP4612,DP4613,AU17011,AU17012,AU18012,AU18012-96,AU1811,AU1812,AU5211110 versions
Fast Real-time Fluorescence PCR Analyzer BTK-8, BTK-12 versions
Disposable Virus Sampling Swab KitsST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-29 versions
Sample Preservation SolutionST7001-3, ST8001-3, ST9001-33 versions
Disposable Virus Sampling Swab KitsZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-57 versions
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)ICA2114-75 versions
Fully Automatic Nucleic Acid Extraction and Detection Integrated MachineBTK-161 version
Disposable sampling swabST001-1, ST001-2, ST001-3，ST001-4, ST001-55 versions
Automated Nucleic Acid Extraction SystemAU1001,AU1001S,AU1001-963 versions
Nucleic Acid Release Reagent (free extraction)ZK1000,ZK15002 versions
PipettePT10, PT50, PT100, PT200, PT1000, PT5000, PTE10, PTE50, PTE100, PTE200, PTE30011 versions
Automated sample transfer processing systemBF40961 version
Consumables for Nucleic Acid ExtractionAU1001-2,AU1001-3,AU1001-53 versions
Disposable specimen collection kitST60011 version
Reaction sample wellBTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00"10 versions
Human chorionic gonadotropin (HCG) Rapid Test Kit (Immunochromatographic Assay)1 test/kit1 version
Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)1 test/kit1 version
Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)1 test/kit1 version
Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)1 version
Saliva Pregnancy Test Kit1 Test/Kit1 version
SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)1 Tests/kit1 version
SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)20 Tests/kit1 version
SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)1 Tests/kit1 version
SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)20 Tests/kit1 version

43 families

Page 1 of 2

Browse all 110 products