HomeChinaGuangdong Softlink Medical Innovation CO., LTD.

Guangdong Softlink Medical Innovation CO., LTD.

China · 广州 · www.gdslmed.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000025833Unified social credit code 91440111668107158W

This company holds 9 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
9China registrations
Class II 9
as of 2026-09-04
EUEuropean UnionEUDAMED
18UDI-DI device records
Class I 18
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 Union18 raw hits, 0 excluded, 18 confirmed
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
China9 certificates (Class III 0 / II 9 / I 0), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000025833
EU authorised representative
Eunitor GmbH
Unified social credit code
91440111668107158W
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
49
Annual revenue
RMB 50–100M
Website
www.gdslmed.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
2007-10-16
Registered capital
CNY 20,833,400
Paid-in capital
CNY 900,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-03-24
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI 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粤械注准20252060110内窥镜荧光冷光源Class II
CN粤械注准202520600634K荧光内窥镜摄像系统Class II
CN粤械注准20242061621电子内窥镜图像处理器Class II
CN粤械注准202220603964K医用内窥镜摄像系统Class II
EU06949567072027UHD Imaging System for Endoscope/ FHD Imaging System for EndoscopeClass I
EU06949567072010UHD Imaging System for Endoscope/ FHD Imaging System for EndoscopeClass I
EU06949567071020UHD Imaging System for Endoscope/ FHD Imaging System for EndoscopeClass I
EU06949567071013UHD Imaging System for Endoscope/ FHD Imaging System for EndoscopeClass I

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