Home›China›Henan Tuoren Medical Device Co.,Ltd.

Henan Tuoren Medical Device Co.,Ltd.

China · Xinxiang Henan · www.tuorenmedical.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000007452Unified social credit code 914107281734449880

This company holds 107 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥100, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

107China registrations

Class I 9Class II 64Class III 34

as of 2026-09-04

EUEuropean UnionEUDAMED

≥100UDI-DI device records

Class I 5Class IIa 95

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

5listed device types

Class I 4Class II 1Class III 0

plus 5 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

28registered device records

Class I 2Class IIa 22Class IIb 1Class III 3

BRBrazilANVISA

35registered devices

Class I 8Class II 27

41 including historic records

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

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 Union5,240 raw hits, 0 excluded, 100 confirmed. Large result set — only the first 300 verified

United States5 registration records, 1 510(k), 0 PMA

China107 certificates (Class III 34 / II 64 / I 9), as of 2026-09-04

United Kingdom28 confirmed, 0 excluded

Brazil35 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: HENAN TUOREN MEDICAL DEVICE CO., LTD. · HENAN TUOREN MEDICAL DEVICE CO. LTD · Henan Tuoren Medical Device Co. Ltd · Henan Tuoren Medical Device Co., Ltd · Henan Tuoren Kingtaek Medical Device Co.Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000007452
EU authorised representative: Lotus NL B.V.
UK responsible person: Horizon Med Tech Ltd
Unified social credit code: 914107281734449880
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1996-07-10
Registered capital: CNY 800,000,000
Paid-in capital: CNY 170,000,000
Legal form: Limited liability company
Industry classification: Technology promotion and application services
Last approval date: 2021-05-14
Recognitions: National High-Tech EnterpriseManufacturing Single ChampionSRDI SMETechnology Innovation Demonstration EnterpriseAbove-designated-size industrial enterprise

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

12016 · K152251

FDA listed device types

Mask, Gas, Anesthetic 1Airway, Oropharyngeal, Anesthesiology 1Condenser, Heat And Moisture (Artificial Nose) 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263031126	一次性使用中心静脉导管及套件	Class III
CN	国械注准20253141925	一次性使用防针刺植入式给药装置专用针	Class III
CN	国械注准20253081745	外周神经丛刺激器	Class III
CN	国械注准20253071717	一次性使用有创压力传感器	Class III
EU	26936186421491	—	Class I
EU	16936186421494	—	Class I
EU	26936186421552	—	Class I
EU	16936186421555	—	Class I
UK	62760	Disposable Blade	Class I
UK	62761	Infant Video Laryngoscope	Class I
UK	10749	Closed Suction Catheter	Class IIa
US	K152251	Endobronchial Tube	2016-06-10
BR	10234409033	Air Flex Circuito para Ventilação Mecânica com 3 vias	Class II
BR	83195680003	Tuoren Ella Pump - Bomba Elastomérica MultiFluxo Ajustável	Class I
BR	83195680004	Tuoren Ella Pump - Bomba elastomérica de Infusão Contínua PCA	Class I
SA	ME0000002243SFDAA00001	medical face mask	—
SA	ME0000002243SFDAA00005	medical face mask	—