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Home›Norway›GE Vingmed Ultrasound AS

GE Vingmed Ultrasound AS

Norway · Horten
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
7listed device types
Class I 1Class II 6Class III 0
plus 133 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class II 8
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class III 3
15 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States133 registration records, 11 510(k), 0 PMA, 2 excluded
Brazil8 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: GE VINGMED ULTRASOUND A/S · GE Vingmed Ultrasound AS · GE VINGMED ULTRASOUND AS

Company information

Country
Norway
City
Horten

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

11999
12009
22010
12012
32013
12014
22015

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Catheter, Ultrasound, Intravascular 1Twister, Brace Setting 1

Registration details (sample)

MarketIdentifierNameClass / date
USK150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System2015-03-04
USK150085GE EchoPAC2015-03-02
USK1410936VT-D ULTRASOUND TRANSDUCER2014-05-15
BR80071269023Sistema de Ultrassom DiagnósticoClass II
BR80071260452EchoPACClass II
BR80071260411Equipamentos de UltrassomClass II
SAME0000003351SFDAA00024TEE Cleaning and Storing System—
CA27335VIVID 5 CARDIOVASCULAR ULTRASOUND SYSTEMClass III
CA34839VIVID 7 ULTRASOUND SYSTEMClass III
CA70440VIVID 7 DIMENSION ULTRASOUND SYSTEMClass III

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