HomeThailandRoyal Industries (Thailand) Public Co. , Ltd.

Royal Industries (Thailand) Public Co. , Ltd.

Thailand · Krathumban
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
14listed device types
Class I 5Class II 9Class III 0
plus 35 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
47registered devices
Class I 47
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
22registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
20 including historic records
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 States35 registration records, 9 510(k), 0 PMA, 10 excluded
Brazil47 confirmed, 3 excluded
Saudi Arabia22 confirmed, 2 excluded
Canada3 confirmed, 2 excluded
Manufacturer names merged into this page: BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LI · SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. · SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED · Sri Trang Gloves (Thailand) Public Company Limited · SRI TRANG GLOVES (THAILAND) Public Co.,Ltd · Sri Trang Gloves (Thailand) Public Company Limited ,

Company information

Country
Thailand
City
Krathumban

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

12005
22020 · K200539
32022 · K221165
32024 · K240266

FDA listed device types

showing 8 of 14
Automated Radiological Image Processing Software 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use 1Pump, Breast, Powered 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)2024-09-09
USK240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue2024-07-02
USK232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)2024-05-13
BR10330660376Luva de Látex para Procedimentos não Cirúrgicos Powder Free DescarpackClass I
BR81628880081Luva látex para procedimento não cirúrgico com póClass I
BR81628880082Luva látex para procedimento não cirúrgico sem póClass I
SAME0000002190SFDAA00003KABAYAN Examination Gloves
SAME0000002190SFDAA00009Nitrile Examination gloves
CA18596SYNTHETIC EXAM GLOVESClass II
CA23570SEMPERCARE SYNTHETIC VINYL EXAMINATION GLOVESClass II
CA69525POLYMED TLC POWDER-FREE LATEX EXAMINATION GLOVESClass II

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