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Home›Taiwan›TAIWAN SURGICAL CORPORATION

TAIWAN SURGICAL CORPORATION

Taiwan · Zhubei City Hsinchu
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel — 7 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
7listed device types
Class I 4Class II 3Class III 0
plus 13 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 1Class II 3
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
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
2valid listings
Class II 1Class III 1
ILIsraelAMAR
5registrations
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 States13 registration records, 8 510(k), 0 PMA, 65 excluded
Brazil4 confirmed, 6 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: TAIWAN SURGICAL CORPORATION · TOP SURGICAL TAIWAN CORP.
Same-named companies — This database also contains companies with near-identical names: TOP SURGICAL TAIWAN CORP.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Taiwan
City
Zhubei City Hsinchu

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

22015 · K150259
12022 · K202994
12023 · K223593
22025 · K253903
22026 · K254231

FDA listed device types

Applier, Surgical, Clip 1Staple, Removable (Skin) 1Stapler, Skin 1Tray, Surgical, Instrument 1Clip, Implantable 1Laparoscope, General & Plastic Surgery 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips2026-07-20
USK252532Inno-Port Disposable Bladed Trocar2026-06-02
USK253903InnoClip Disposable Clip Applier2025-12-22
BR81758810001APLICADOR DE CLIPES REUTILIZÁVEL INNOCLIPClass I
BR81758819001AGULHA DE VERESS PNEUMOCATTISClass II
BR81758819002TROCARTE INNOPORT CATTIS MEDICALClass II

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