Manufacturer
GE Medical Systems SCS
France
Markets : Austria · Belgium · France · Germany · Ireland · Italy · Poland · Spain · United States
Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 40 · class II · latest in 2026 · see on the FDA website
Public contracts won : France 2
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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