HomeChinaHenan Tuoren Kingtaek Medical Device Co., Ltd

Henan Tuoren Kingtaek Medical Device Co., Ltd

China · 新乡 · www.tuoren.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000015021Unified social credit code 9141072807780543XF

This company holds 17 NMPA certificates in China and has registrations in European Union, United Kingdom, Saudi Arabia, Taiwan, Hong Kong — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
17China registrations
Class II 17
as of 2026-09-04
EUEuropean UnionEUDAMED
39UDI-DI device records
Class I 35Class IIa 4
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 2
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class II 1
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 Union39 raw hits, 0 excluded, 39 confirmed
China17 certificates (Class III 0 / II 17 / I 0), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Henan Tuoren Kingtaek Medical Device Co.Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000015021
EU authorised representative
MedNet EC-REP GmbH
UK responsible person
Horizon Med Tech Ltd
Unified social credit code
9141072807780543XF
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
75
Annual revenue
RMB 50–100M
Website
www.tuoren.com
Product categories
手术室及急救

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
2013-08-29
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Pharmaceutical manufacturing
Last approval date
2023-07-18
Recognitions
National High-Tech EnterpriseSRDI 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN豫械注准20262080280一次性使用气管插管套件Class II
CN豫械注准20252020460一次性使用泌尿取石网篮Class II
CN豫械注准20242080368视频气管插管用喉镜Class II
CN豫械注准20242060347一次性电子鼻咽喉内窥镜Class II
EU06970524034581Class I
EU06970524030897Class I
EU06970524034574Class I
EU06970524030880Class I
UK62760Disposable BladeClass I
UK62761Infant Video LaryngoscopeClass I
SAML0000000177SFDAA00001Video Laryngoscope

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