HomeChinaShanghai Keensea Medical Co.,Ltd.

Shanghai Keensea Medical Co.,Ltd.

China · 上海 · www.keensea.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000034377Unified social credit code 91310114MA1GXM345R

This company holds 31 NMPA certificates in China and has registrations in European Union, Australia — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
31China registrations
Class I 20Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
1UDI-DI device records
Class I 1
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(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
2active ARTG entries
Class I 2
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 Union1 raw hits, 0 excluded, 1 confirmed
China31 certificates (Class III 0 / II 11 / I 20), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000034377
EU authorised representative
Sungo Cert GmbH
Unified social credit code
91310114MA1GXM345R
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
16
Annual revenue
under RMB 5M
Website
www.keensea.com

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
2021-01-14
Registered capital
CNY 30,000,000
Paid-in capital
CNY 30,000,000
Legal form
Limited liability company (Sino-foreign joint venture)
Industry classification
Technology promotion and application services
Last approval date
2024-11-01
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20252060396腹腔内窥镜Class II
CN沪械注准20252060294三维荧光内窥镜图像处理器Class II
CN沪械注准20252060283内窥镜用荧光冷光源Class II
CN沪械注准20252060280医用一体化内窥镜摄像系统Class II
EU06976162660069Class I

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