HomeChinaGuangzhou T.K Medical Instrument Co.,Ltd

Guangzhou T.K Medical Instrument Co.,Ltd

China · Guangzhou Guangdong · www.tk-medical.com
✓ Record-verifiedregistrations found in 6 marketsUnified social credit code 9144011675940764XQ

This company holds 22 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Canada, South Korea — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
22China registrations
Class I 10Class II 12
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
15listed device types
Class I 5Class II 10Class III 0
plus 18 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
22registered device records
Class I 5Class IIa 17
BRBrazilANVISA
16registered devices
Class I 2Class II 14
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
11 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union6,013 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States18 registration records, 13 510(k), 0 PMA, 164 excluded
China22 certificates (Class III 0 / II 12 / I 10), as of 2026-09-04
United Kingdom22 confirmed, 32 excluded
Brazil16 confirmed, 96 excluded
Saudi Arabia0 confirmed, 31 excluded
Canada0 confirmed, 22 excluded
Manufacturer names merged into this page: GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD. · GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD. · GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD. · GUANGZHOU TK MEDICAL INSTRUMENT CO.,LTD

Regulatory identity

UK responsible person
Wellkang Ltd
Unified social credit code
9144011675940764XQ
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Guangzhou Guangdong
Social-insurance enrolees
154
Annual revenue
RMB 50–100M
Website
www.tk-medical.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
2004-03-03
Registered capital
CNY 18,000,000
Paid-in capital
CNY 18,000,000
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2024-05-14
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle enterpriseTorch Programme enterpriseInnovative SME

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

12010
22020
12023
52024 · K241987
32025 · K251951
12026 · K253131

FDA listed device types

showing 8 of 15
Cystoscope And Accessories, Flexible/Rigid 1Pneumoperitoneum Needle 1Hysteroscope (And Accessories) 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Insufflator, Laparoscopic 1Colonoscope And Accessories, Flexible/Rigid 1Ring (Wound Protector), Drape Retention, Internal 1Ureteroscope And Accessories, Flexible/Rigid 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262180665一次性使用可视流产吸引管Class II
CN粤械注准202620605894K内窥镜摄像系统Class II
CN粤械注准20262060358医用内窥镜冷光源Class II
CN粤械注准20262060066医用内窥镜冷光源Class II
UK35775Curing LightClass I
UK16355Apex LocatorClass IIa
UK56654Endoscopic Video Image ProcessorClass I
USK253131Curing Light (M-Cure 6)2026-06-18
USK251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)2025-12-16
USK252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)2025-08-08
BR80603600033ENDOBAG - TKBAGClass II
BR80603600038Agulha de VerresClass I
BR80603600036Trocarter descartávelClass I

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