HomeTaiwanLAGIS ENTERPRISE Co., Ltda.

LAGIS ENTERPRISE Co., Ltda.

Taiwan · Taichung
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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 3 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
16registered devices
Class II 16
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
5active device licences
Class II 5
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 States3 registration records, 5 510(k), 0 PMA
Brazil16 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: Lagis Enterprise Co., Ltd. · LAGIS ENTERPRISE CO., LTD · LAGIS ENTERPRISE Co., Ltda. · LAGIS ENTERPRISE CO., LTD. · Lagis Enterprise Co,Ltd.
Same-named companies — This database also contains companies with near-identical names: Lagis Enterprises Co, Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Taiwan
City
Taichung

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

12009 · K090309
12015 · K141902
12024 · K240334
12025 · K243867
12026 · K253134

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253134LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)2026-05-20
USK243867LAGIS Suction Irrigation System2025-03-17
USK240334LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)2024-10-30
BR10289680146Cânula com trocarte descartável para procedimentos endoscópicos LAGISClass II
BR10289680147Cânula com trocarte descartável para procedimentos endoscópicos Com lâClass II
BR10289680095Bolsa coletora de espécime descartável para procedimentos endoscópicosClass II
CA90931SURGICAL TROCAR SETSClass II
CA92613ENDOSCOPIC INSTRUMENTSClass II
CA92614SURGICAL TROCAR-LAGIPORT MULTIPLE INSTRUMENT ACCESS PORTClass II

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