Manufacturer
Gynesonics
United StatesLegal entities : Gynesonics, Inc.
Markets : Belgium · Netherlands · United States
Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 8 · class II · latest in 2025 · see on the FDA website
EU representative : Obelis s.a. (Belgium)
- 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 |
|---|---|---|---|---|
| Gynaecology and fertility treatment instruments - hardware accessories | Z12080280 | I MDR | EUDAMED record Report an error | |
| Gynaecology and fertility treatment instruments - other | Z12080299 | IIb MDR | EUDAMED record Report an error | |
| Endocavitary ultrasound probes, two-dimensional | Z1104020201 | IIa MDR | EUDAMED record Report an error |
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