HomeTaiwanSTURDY INDUSTRIAL CO., LTD.

STURDY INDUSTRIAL CO., LTD.

Taiwan · Taipei Hsien
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Hong Kong — 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
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class III 1
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 States2 registration records, 3 510(k), 0 PMA
Manufacturer names merged into this page: STURDY INDUSTRIAL CO., LTD. · STURDY INDUSTRIAL CO. LTD

Company information

Country
Taiwan
City
Taipei Hsien

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

12004 · K032596
12019 · K181993
12023 · K231489

FDA listed device types

Sterilizer, Steam 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231489Sturdy Autoclave Super Microm2023-06-21
USK181993STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)2019-11-01
USK032596STURDY MANUAL RESUSCITATOR2004-08-05

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