HomeChinaChangzhou Sinolinks Medical Innovation Co., Ltd.

Changzhou Sinolinks Medical Innovation Co., Ltd.

China · Shanghai
✓ 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
5listed device types
Class I 3Class II 2Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class I 4Class II 8
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 States5 registration records, 2 510(k), 0 PMA
Brazil12 confirmed, 0 excluded
Manufacturer names merged into this page: Sinolinks Medical Innovation, Inc. · SINOLINKS MEDICAL INNOVATION, INC.
Same-named companies — This database also contains companies with near-identical names: Sinolinks Medical Innovation, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Shanghai

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

12013 · K131511
12025 · K250820

FDA listed device types

Instrument, Surgical, Disposable 1Applier, Surgical, Clip 1Stapler, Skin 1Staple, Implantable 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250820Disposable Trocars2025-07-11
USK131511DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR2013-07-05
BR80856019019Grampeador descartáveis para cortadores lineares endoscópicos DEC A / Class II
BR80856019001Trocarte Descartável com Lâmina.Class II
BR80856019013Grampeador de pele descartáveisClass II

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