HomeChinaEzisurg (Suzhou) Medical Co., Ltd.

Ezisurg (Suzhou) Medical Co., Ltd.

China · Suzhou
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 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
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 4 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
10 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
9 including historic records
TWTaiwanTFDA
5valid device licences
Class II 5
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.

United States4 registration records, 7 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: EZISURG MEDICAL CO., LTD.
Same-named companies — This database also contains companies with near-identical names: EZISURG MEDICAL CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Suzhou

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

12015 · K143129
12017 · K172960
12018 · K181620
32019 · K182217
12021 · K210909

FDA listed device types

Staple, Implantable 1Stapler, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use2021-06-24
USK182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use2019-04-16
USK183477easyPPHTM Hemorrhoidal Stapler for Single Use2019-02-11
BR80117589158easyEndo Lite Linear Cutting Stapler for Single UseClass II
BR80117589164easyEndo Single Use TrocarClass II
BR83432889001easyEndo Single Use TrocarClass II

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