HomeChinaAnhui Tiankang Medical Technology Co., Ltd

Anhui Tiankang Medical Technology Co., Ltd

China · Tianchang Anhui · www.tkmedical.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000017064Unified social credit code 9134110071990801XY

This company holds 35 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
35China registrations
Class I 6Class II 8Class III 21
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 7Class IIa 293
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
9listed device types
Class I 1Class II 8Class III 0
plus 17 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
10registered device records
Class I 1Class IIa 9
BRBrazilANVISA
5registered devices
Class I 5
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
IIa 8
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union614 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States17 registration records, 13 510(k), 0 PMA
China35 certificates (Class III 21 / II 8 / I 6), as of 2026-09-04
United Kingdom10 confirmed, 0 excluded
Brazil5 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. · ANHUI TIANKANG MEDICAL TECHNOLOGY CO. LTD · ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000017064
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
RPG Medical Limited
Unified social credit code
9134110071990801XY
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Tianchang Anhui
Social-insurance enrolees
668
Annual revenue
over RMB 500M
Website
www.tkmedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2000-01-21
Registered capital
CNY 57,780,000
Paid-in capital
CNY 300,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-07-19
Recognitions
National High-Tech EnterpriseSRDI SMERecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing
Delisted from the NEEQ

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12014
12019
42020 · K191639
22021 · K212368
22022 · K222385
32023 · K222772

FDA listed device types

showing 8 of 9
Dispenser, Liquid Medication 1Allergen And Vaccine Delivery Needles 1Syringe, Piston 1Syringe, Antistick 1Enteral Syringes With Enteral Specific Connectors 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Gastrointestinal Tubes With Enteral Specific Connectors 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253140748预充式导管冲洗器Class III
CN国械注准20253140536静脉输液过滤器Class III
CN国械注准20243140238一次性使用植入式给药装置专用针Class III
CN国械注准20243140113一次性使用滴定管式输液器 带针Class III
EU06934841543911Class IIa
EU06934841543904Class IIa
EU06934841543898Class IIa
EU06934841526211Class IIa
UK65416EZ-IVClass IIa
UK58977EZ-IV AdminClass IIa
UK58497EZ-IVClass IIa
USK222772Oral/Enteral Syringe with ENFit connector2023-08-17
USK222773Feeding Tube2023-08-17
USK230756TK Pre-Filled Normal Saline Flush Syringe2023-08-12
BR82812710005NEEDS SERINGA PARA LAVAGEM NASALClass I
BR82812710004FREEDOM SERINGA PARA LAVAGEM NASALClass I
BR80239540003Equipo GravitacionalClass I

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