Ge Hangwei Medical Systems Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000009292 FEI 3002175190
- Devices
- 29
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 2 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
- Authorised rep.
- GE Medical Systems SCSFR
Catalogue
Revolution Apex Nexus Ref Revolution Apex Nexus
Revolution Altitude Elite Ref Revolution Altitude Elite
Revolution RT Ref Revolution RT B7590AE
Discovery RT Ref B79522DA, B7590MF
Revolution Apex Expert Ref Revolution Apex Expert
Revolution Advance Ref Revolution Advance
Revolution Frontier ES Ref Revolution Frontier ES
Brivo MR355, Optima MR360 Ref K103330
OEC Elite MiniView Ref K160131
Optima CT520 Ref K123596
Brivo MR355 Ref K120778
Revolution Ascend Sliding Ref K233749
Revolution ACT Ref K171013
Ge 8CH Foot Ankle Coil Ref K122694
Brivo MR355, Optima MR360 Ref K123417
Auto Positioning Ref K192956
Revolution Maxima, Revolution Ace Ref K192686
Console Generation Upgrade Ref Console Generation Upgrade
Revolution Vibe Ref B7920HEC/B7920HFC
Revolution Apex Select with Plus Edition Ref Revolution Apex Select with Plus Edition
Revolution Apex Select with Elite Edition Ref Revolution Apex Select with Elite Edition
MaxFOV 2 Ref MaxFOV 2
Revolution Apex Select Ref Power Xtream: B7919QT; Power Pro: B7919QS
Revolution Maxima Ref Revolution Maxima
Revolution Altitude Plus Ref Revolution Altitude Plus
Revolution Frontier Ref Revolution Frontier
RT Refresh Package Ref B79612DA, B79602DA
Revolution Frontier Gen 3_HD Refresh Package Ref B79832DA
Revolution RT Ref B81912DA, B7590AE
Company details
- EUDAMED SRN
- CN-MF-000009292
- FDA FEI number
- 3002175190
- EUDAMED status
- Active
- EUDAMED registered name
- GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- EUDAMED abbreviated name
- GEHW
- Registered address
- West Area of Building No.3, No.1 Yongchang North Road, Beijing Economic and Technological Development Area, 100176, Beijing, China
- [email protected]
- PRRC contact
- Ying Sun
EUDAMED certificates
2 certificates1 valid, 1 expiredMDR 2next expiry 12 Jan 2031
TÜV Rheinland LGA Products GmbH 0197 2 certificates
- HZ 2069064-1 Reissued
Quality management system EU MDR
- Issued
- 1 Dec 2025
- Expires
- 12 Jan 2031
- Valid from
- 13 Jan 2026
- HZ 2069064-1 Expired
Quality management system EU MDR
- Issued
- 25 Oct 2021
- Expires
- 12 Jan 2026
Frequently asked questions
How many devices does GE HANGWEI MEDICAL SYSTEMS CO., LTD. have in the registry?
The registry currently lists 29 devices for GE HANGWEI MEDICAL SYSTEMS CO., LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GE HANGWEI MEDICAL SYSTEMS CO., LTD.'s devices?
Among its 29 most recently registered devices, GE HANGWEI MEDICAL SYSTEMS CO., LTD. has devices listed in EUDAMED (19 devices), FDA 510(k) (10 devices) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GE HANGWEI MEDICAL SYSTEMS CO., LTD.'s devices fall under?
Among its 29 most recently registered devices, the classes recorded for GE HANGWEI MEDICAL SYSTEMS CO., LTD.'s devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for GE HANGWEI MEDICAL SYSTEMS CO., LTD.?
EUDAMED lists 2 certificates for GE HANGWEI MEDICAL SYSTEMS CO., LTD. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-12-01.
What are the newest devices from GE HANGWEI MEDICAL SYSTEMS CO., LTD. in the registry?
The most recently registered devices listed for GE HANGWEI MEDICAL SYSTEMS CO., LTD. include Revolution Apex Nexus, Revolution Altitude Elite, Revolution RT and Discovery RT.