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Ge Hangwei Medical System Co., Ltd.

China · Beijing
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
22listed device types
Class I 6Class II 16Class III 0
plus 70 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
10 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
4active device licences
Class III 4
23 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 States70 registration records, 11 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: GE HANGWEI MEDICAL SYSTEMS CO., LTD. · GE HANGWEI MEDICAL SYSTEMS CO. LTD. · GE HANGWEI MEDICAL SYSTEMS CO. LTD
Same-named companies — This database also contains companies with near-identical names: GE HANGWEI MEDICAL SYSTEMS CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Beijing

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

12011
22012
22013
22016
12017
12019
12020
12024

FDA listed device types

showing 8 of 22
Holder, Radiographic Cassette, Wall-Mounted 1Bed, Scanning, Nuclear 1Support, Patient Position 1Instrument, Quality-Assurance, Radiologic 1Assembly, Tube Housing, X-Ray, Diagnostic 1Tube Mount, X-Ray, Diagnostic 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1Automated Radiological Image Processing Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233749Revolution Ascend Sliding2024-02-22
USK192956Auto Positioning2020-01-16
USK192686Revolution Maxima, Revolution Ace2019-10-24
BR80071260125SISTEMA DE IMAGEM POR RESSONÂNCIA MAGNÉTICAClass II
BR80071260126SISTEMA DE IMAGEM POR RESSONÂNCIA MAGNÉTICAClass II
CA29420LIGHTSPEED PLUS CT SCANNER SYSTEMClass III
CA67510HISPEED CT DUAL CT SCANNER SYSTEMClass III
CA69035LIGHTSPEED VFX PLUS CT SCANNER SYSTEMClass III

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