HomeChinaSYKERS Endoscope Technology(Xuzhou) Co., Ltd.

SYKERS Endoscope Technology(Xuzhou) Co., Ltd.

China · 徐州
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000046799Unified social credit code 91320312MA263EN07R

This company holds 5 NMPA certificates in China and has registrations in European Union — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
127UDI-DI device records
Class I 127
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
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 Union127 raw hits, 0 excluded, 127 confirmed
China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000046799
EU authorised representative
Kingsmead Service B.V.
Unified social credit code
91320312MA263EN07R
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
10
Annual revenue
under RMB 5M
Product categories
医用成像器械手术器械

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
2021-05-21
Registered capital
CNY 1,000,000
Paid-in capital
CNY 850,000
Legal form
Limited liability company
Industry classification
Wholesale trade
Last approval date
2025-05-21
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SME

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20262061093内窥镜荧光冷光源Class II
CN苏械注准20262061089内窥镜气腹机Class II
CN苏械注准202420619014K内窥镜荧光摄像系统Class II
CN苏械注准20242061203内窥镜摄像系统Class II
EU06978385971533Medical Endoscope Cold Light SourceClass I
EU06978385971519Integrated 4K Endoscope Camera SystemClass I
EU06978385971526Integrated 4K Endoscope Camera SystemClass I
EU06978385971502Endoscope Fluorescence Cold Light SourceClass I

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