Manufacturer
Ge Hualun Medical Systems
ChinaLegal entities : GE HUALUN MEDICAL SYSTEMS CO. Ltd
Markets : Austria · France · Germany · Ireland · Italy · Poland · Romania · Türkiye · United States
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 12 · class II · latest in 2025 · see on the FDA website
EU representative : GE Medical Systems SCS (France)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Multifunctional systems for direct digital radiology | Z11031101 |
6 others
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| CT/gamma camera systems | Z11020201 |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Mobile radioscopic units | Z11039017 | IIb MDR | EUDAMED record Report an error | |
| Various digital bioimaging management instruments - medical device software | Z11069092 | IIa MDR, 93/42 | EUDAMED record Report an error | |
| Fixed station gamma cameras with multiple heads - with ‘total body’ acquisition | Z11020105 |
|
IIa 93/42 | EUDAMED record Report an error |
| Stationary angiography systems for angiographic and cardiologic studies | Z11030102 | IIb MDR | EUDAMED record Report an error |
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