HomeTaiwanDHEF INC.

DHEF INC.

Taiwan · New Taipei City
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Israel — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
21listed device types
Class I 17Class II 4Class III 0
plus 21 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
19registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
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 States21 registration records, 0 510(k), 0 PMA
Saudi Arabia19 confirmed, 0 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: DHEF INC.

Company information

Country
Taiwan
City
New Taipei 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 listed device types

showing 8 of 21
Light, Fiber Optic, Dental 1Bur, Dental 1Handpiece, Direct Drive, Ac-Powered 1Illuminator, Radiographic-Film 1Mirror, Mouth 1Unit, Operative Dental, Accessories 1Light, Operating, Dental 1Tray, Impression, Preformed 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000011796SFDAA00001Dentamerica
SAME0000011796SFDAA00002Dentamerica
CA95777ULTRASONIC SCALERSClass II
CA95778PHOSPHOROUS PLATE SCANNERSClass II
CA95779ENDODONTIC HANDPIECESClass II

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