HomeKorea, RepublicDEXCOWIN CO., LTD.

DEXCOWIN CO., LTD.

Korea, Republic · Seoul
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Russia — 5 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 2Class II 4Class III 0
plus 9 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States9 registration records, 5 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: DEXCOWIN CO., LTD.

Company information

Country
Korea, Republic
City
Seoul

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 · K083532
22014 · K134055
12015 · K143494
12017 · K173046

FDA listed device types

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1System, X-Ray, Mobile 1System, X-Ray, Extraoral Source, Digital 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Bracket, Metal, Orthodontic 1Tube Mount, X-Ray, Diagnostic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK173046Cocoon Portable Handheld X-Ray System2017-10-26
USK143494ADX6000 Portable X-Ray System; iRayA62015-10-05
USK134055ADX4000W2014-05-09

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