HomeChinaShenyang shenda Endoscope Co., Ltd.

Shenyang shenda Endoscope Co., Ltd.

China · 沈阳 · www.china-endoscpe.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000030478Unified social credit code 91210112410722145F

This company holds 75 NMPA certificates in China and has registrations in European Union, United States, Brazil, Israel — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
75China registrations
Class I 8Class II 60Class III 5
as of 2026-09-04
EUEuropean UnionEUDAMED
185UDI-DI device records
Class I 59Class IIa 108Class IIb 18
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
49registered devices
Class I 28Class II 21
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
2registrations
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 Union185 raw hits, 0 excluded, 185 confirmed
United States0 registration records, 1 510(k), 0 PMA
China75 certificates (Class III 5 / II 60 / I 8), as of 2026-09-04
Brazil49 confirmed, 0 excluded
Manufacturer names merged into this page: SHENYANG SHENDA ENDOSCOPE CO., LTD. · SHENYANG SHENDA ENDOSCOPE CO., LTD. (BEIDAYING STREET)

Regulatory identity

EU manufacturer SRN
CN-MF-000030478
EU authorised representative
Lepu Medical (Europe) Cooperatief U.A.
Unified social credit code
91210112410722145F
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
278
Annual revenue
over RMB 500M
Website
www.china-endoscpe.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
1999-04-08
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
2023-12-20
Recognitions
National High-Tech EnterpriseSRDI SMERecognised enterprise technology centre

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

12017 · K161298

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263010304一次性使用等离子手术电极Class III
CN国械注准20173063258双极电切内窥镜Class III
CN国械注准20173060885电切内窥镜Class III
CN国械注准20163011224腹腔内窥镜专用有源手术器械Class III
EU06971244214468Class I
EU06971244214321Class I
EU06980426490002Class I
EU06971244214314Class I
USK161298ShenDa Sinuscope2017-08-25
BR81594020002Trocater ArgusClass I
BR80690340022INSTRUMENTAL CIRÚRGICO PARA VIDEOCIRURGIA COM CONEXÃO NÃO ARTICULADO NClass I
BR81425780015ARTROSCÓPICO OLTRAMEDClass II

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