HomeKorea, RepublicTHE STANDARD CO., LTD.

THE STANDARD CO., LTD.

Korea, Republic · Gunpo-Si
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, Russia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
6listed device types
Class I 0Class II 6Class III 0
plus 13 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
2 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 3 1
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, 2 510(k), 0 PMA, 27 excluded
Brazil2 confirmed, 7 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: THE STANDARD CO., LTD. · THE STANDARD CO.,LTD. · THE STANDARD CO.

Company information

Country
Korea, Republic
City
Gunpo-Si

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

12022 · K220434
12024 · K241591

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Marker, Colon 1Massager, Vacuum, Radio Frequency Induced Heat 1Catheter, Ultrasound, Intravascular 1Powered Laser Surgical Instrument 1Submucosal Injection Agent 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241591Blue Eye2024-07-03
USK220434Blue Eye (TS-905)2022-08-12
BR82214249002marcador endoscópico black eyeClass II
BR82214249003Agente Marcador de Submucosa Blue EyeClass II

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