HomeChinaChangzhou Xin Neng Yuan Medical Stapler Co., Ltd

Changzhou Xin Neng Yuan Medical Stapler Co., Ltd

China · Changzhou
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
7510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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.

United States0 registration records, 7 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 1 excluded
Manufacturer names merged into this page: Changzhou Xin Neng Yuan Medical Stapler Co., Ltd · CHANGZHOU KANGDI MEDICAL STAPLER CO LTD

Company information

Country
China
City
Changzhou

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

12010 · K100723
12012 · K121474
12016 · K161905
22017 · K172561
12019 · K190029
12025 · K250389

Registration details (sample)

MarketIdentifierNameClass / date
USK250389XNY Disposable Gastric Calibration Tube2025-04-10
USK190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar2019-09-26
USK172561Disposable Circular Stapler2017-12-05
BR80693240008Cânula Trocarte com Lâmina LABMEDICALClass II
BR10349009049Grampeador Linear Endoscópico Elétrico DescartávelClass II

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