HomeChinaDongguan Senmed Medical Instrument Co. Ltd.

Dongguan Senmed Medical Instrument Co. Ltd.

China · senmedor.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000028972Unified social credit code 91441900MA4UQBE7X5

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Australia, Israel — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class I 1Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
107UDI-DI device records
Class I 97Class IIa 10
USUnited StatesFDA openFDA
3listed device types
Class I 3Class II 0Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
11registered device records
Class I 7Class IIa 4
BRBrazilANVISA
0registered devices
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIa 2Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union122 raw hits, 15 excluded, 107 confirmed
United States3 registration records, 0 510(k), 0 PMA
China4 certificates (Class III 0 / II 3 / I 1), as of 2026-09-04
United Kingdom11 confirmed, 0 excluded
Manufacturer names merged into this page: DONGGUAN SENMED MEDICAL INSTRUMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000028972
EU authorised representative
Wellkang Ltd
UK responsible person
Wellkang Ltd
Unified social credit code
91441900MA4UQBE7X5
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
22
Annual revenue
RMB 30–50M
Website
senmedor.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
2016-06-03
Registered capital
CNY 1,000,000
Paid-in capital
CNY 1,000,000
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2024-10-18
Recognitions
Micro and small 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 listed device types

Passer 1Accessories, Cleaning Brushes, For Endoscope 1Retractor 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252021081一次性使用外科牵开器Class II
CN粤械注准20222020499一次性使用腹腔镜用穿刺器Class II
CN粤械注准20202061567一次性使用内窥镜标本取物袋Class II
CN粤东械备20240127号聚酯衬垫Class I
EU06975833142446Class IIa
EU06975833143054Class IIa
EU06975833143047Class I
EU06975833140886Class I
UK60738Disposable Sterilized Laparoscopic Surgical Instruments Filter with Tubing SetClass IIa
UK44977Disposable Sterilized Laparoscopic Surgical Instruments Light Handle CoverClass I
UK58976Disposable Sterilized Laparoscopic Surgical Instruments Camera DrapeClass I

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