HomeChinaHUNAN KMS MEDICAL TECHNOLOGY CO.,LTD

HUNAN KMS MEDICAL TECHNOLOGY CO.,LTD

China · 长沙 · www.kms-med.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000051907Unified social credit code 91430111MA4QR1WYX8

This company holds 35 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
35China registrations
Class I 1Class II 34
as of 2026-09-04
EUEuropean UnionEUDAMED
1UDI-DI device records
Class I 1
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
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 Union7 raw hits, 6 excluded, 1 confirmed
United States0 registration records, 2 510(k), 0 PMA
China35 certificates (Class III 0 / II 34 / I 1), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000051907
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91430111MA4QR1WYX8
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
98
Annual revenue
RMB 10–30M
Website
www.kms-med.com
Product categories
医用成像器械

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
2019-09-10
Registered capital
CNY 20,000,000
Paid-in capital
CNY 6,700,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2026-08-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SME

Business registration data from Tianyancha, as of 2026-09-03. 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

12007 · K063654
12026 · K252858

Registration details (sample)

MarketIdentifierNameClass / date
CN湘械注准20262180391一次性宫腔组织切除装置Class II
CN湘械注准20262180041宫腔镜Class II
CN湘械注准20262060319医用内窥镜图像处理器Class II
CN湘械注准20262060270超声内窥镜图像处理装置Class II
EU169763949311704K UHD Endoscopy Camera SystemClass I
USK2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)2026-04-30
USK063654ENDOGUIDE2007-01-31

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