HomeChinaGolden Stapler Surgical Co. Ltd

Golden Stapler Surgical Co. Ltd

China · Changzhou Jiangsu · www.goldenstapler.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000014070

This company has registrations in European Union, United States, Brazil, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
87UDI-DI device records
Class IIa 31Class IIb 56
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
7registered devices
Class II 7
12 including historic records
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
3active ARTG entries
IIa 2IIb 1
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 Union256 raw hits, 169 excluded, 87 confirmed
United States0 registration records, 1 510(k), 0 PMA, 2 excluded
United Kingdom0 confirmed, 2 excluded
Brazil7 confirmed, 2 excluded
Manufacturer names merged into this page: GOLDEN STAPLER SURGICAL CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000014070
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)

Company information

Country
China
City
Changzhou Jiangsu
Website
www.goldenstapler.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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.

FDA 510(k) clearances by year

12017 · K162707

Registration details (sample)

MarketIdentifierNameClass / date
EU06946912242036Golden Stapler Class IIa
EU06946912242029Golden Stapler Class IIa
EU06946912242012Golden Stapler Class IIa
EU06946912241039Golden Stapler Class IIa
USK162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload2017-07-14
BR80351249021BOLSA COLETORA DE ESPÉCIMESClass II
BR80351249022BOLSA COLETORA DE ESPÉCIMES DE USO ÚNICOClass II
BR80351249023CÂNULA GOLDEN STAPLERClass II

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