Manufacturer
Ge Medical Systems Ultrasound Primary Care Diagnostics
United StatesLegal entities : GE Medical Systems Ultrasound and Primary Care Diagnostics LLC, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Markets : Austria · Finland · France · Greece · Italy · Northern Ireland · Romania · Spain · United States
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 85 · class II · latest in 2026 · 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 |
|---|---|---|---|---|
| Internal ultrasound scanners | Z11040101 |
|
IIa MDR | EUDAMED record Report an error |
| Ultrasound scanners - software accessories | Z11040182 | IIa MDR | EUDAMED record Report an error | |
| X-ray bone densitometers | Z11900103 |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Ultrasound scanners - medical device software | Z11040192 | IIa MDR | EUDAMED record Report an error |
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