HomeUSADGH TECHNOLOGY, INC.

DGH TECHNOLOGY, INC.

USA · Exton
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 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
2listed device types
Class I 0Class II 2Class III 0
plus 7 registration records and 7 510(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
2 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
4device registrations
CLASS B 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States7 registration records, 7 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: DGH TECHNOLOGY, INC. · DGH TECHNOLOGY INC.

Company information

Country
USA
City
Exton

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

11987 · K872726
21992 · K920906
11997 · K965127
12003 · K033385
12010 · K093371
12017 · K171301

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171301Scanmate Flex2017-07-31
USK093371MODEL DGH 6000 SCANMATE A2010-04-05
USK033385DGH 55 HANDHELD PACHYMETER (PACHMATE)2003-11-07

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