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GE Medical System SCS

✓ 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
19listed device types
Class I 4Class II 14Class III 1
plus 124 registration records and 41 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 1Class II 3
11 including historic records
SASaudi ArabiaSFDA
9registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
13active device licences
Class II 5Class III 8
36 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 States124 registration records, 41 510(k), 0 PMA, 2 excluded
Brazil4 confirmed, 0 excluded
Saudi Arabia9 confirmed, 0 excluded
Canada13 confirmed, 0 excluded
Manufacturer names merged into this page: GE MEDICAL SYSTEMS SCS · GE MEDICAL SYSTEMS SCS (GEMS SCS) · GE Medical System SCS · GE Medical Systems Scs
Same-named companies — This database also contains companies with near-identical names: GE MEDICAL SYSTEMS SCS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

12008
22009
12011
52012
12013
22014
22016
12017
12018
22019
52020
32021
42022
32023
22024
42025
22026

FDA listed device types

showing 8 of 19
Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Tomography, Computed, Emission 1System, Nuclear Magnetic Resonance Imaging 1System, Simulation, Radiation Therapy 1Full Field Digital, System, X-Ray, Mammographic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253770CardIQ Suite2026-07-21
USK260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright2026-03-24
USK251199Allia Moveo2025-12-09
BR80071260382DoseWatchClass I
BR80071260370SenoIrisClass II
BR80071260131ESTAÇÃO DE TRABALHO AWClass II
SAME0000009143SFDAA00003DoseWatch—
SAME0000003337SFDAA00023STATORIX—
CA13104ADVANTX LCV+ ANGIOGRPHIC SYSTEMClass III
CA13877ADVANTX LCN+ ANGIOGRAPHIC SYSTEMClass III
CA13923SENOVISIONClass III

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