HomeTaiwanCodent Technical Industry Co., Ltd.

Codent Technical Industry Co., Ltd.

Taiwan · Kaohsiung City
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, South Korea, Australia, Israel, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 3Class II 0Class III 0
plus 5 registration records and 5 510(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
4active device licences
Class II 4
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States5 registration records, 5 510(k), 0 PMA
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: CODENT TECHNICAL INDUSTRY CO.,LTD. · CODENT TECHNICAL INDUSTRY CO., LTD

Company information

Country
Taiwan
City
Kaohsiung City

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 · K033213
12014 · K133069
22015 · K152146
12024 · K231864

FDA listed device types

Controller, Foot, Handpiece And Cord 1Handpiece, Air-Powered, Dental 1Handpiece, Contra- And Right-Angle Attachment, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231864Fiber Optic Brushless Electronic Micromotor, model: iM1002024-03-11
USK152146High Speed Handpieces and Accessories2015-12-08
USK150798Codent Low Speed Dental Handpieces and Accessories2015-04-24
CA94264CODENT COUPLINGClass II
CA94266CODENT HIGH SPEED DENTAL HANDPIECEClass II
CA94267CODENT AIR MOTORClass II

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