HomeKorea, RepublicRemedi Co., Ltd.

Remedi Co., Ltd.

Korea, Republic · Chuncheon Gangwon
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Australia, Israel, Russia — 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
3listed device types
Class I 0Class II 3Class III 0
plus 5 registration records and 4 510(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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
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 States5 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: REMEDI INC.

Company information

Country
Korea, Republic
City
Chuncheon Gangwon

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

12020 · K200284
12021 · K212144
12024 · K240759
12025 · K250597

FDA listed device types

Unit, X-Ray, Extraoral With Timer 1System, X-Ray, Extraoral Source, Digital 1System, X-Ray, Mobile 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250597REMEX Xcam62025-07-31
USK240759REMEX-GR1002024-05-13
USK212144Remex KA62021-08-03

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