HomeKorea, RepublicCOWELLMEDI CO., LTD.

COWELLMEDI CO., LTD.

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

This company has registrations in United States, Canada, Taiwan, Hong Kong, 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 3Class II 3Class III 0
plus 11 registration records and 14 510(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
5 including historic records
TWTaiwanTFDA
5valid device licences
Class II 4Class III 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class IV 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
7active registrations
Class 1 2Class 2a 3Class 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 States11 registration records, 14 510(k), 0 PMA
Manufacturer names merged into this page: COWELLMEDI CO., LTD.

Company information

Country
Korea, Republic
City
Busan

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
12005
12008
22009
12010
12013
12022
42023
12024
12025

FDA listed device types

Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Barrier, Synthetic, Intraoral 1Drill, Dental, Intraoral 1Screwdriver, Surgical 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242287SFIT Abutment2025-09-16
USK241127INNO SLA Mini Plus® Implant System2024-12-27
USK231411INNO SLA Submerged Hybrid Ti-Base System2023-12-20

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