Manufacturer
FHC
United StatesLegal entities : FHC Inc.
Markets : France · Romania · Spain · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 12 · class I, II · latest in 2023 · see on the FDA website
EU representative : TERMOBIT PROD SRL (Romania)
- 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 |
|---|---|---|---|---|
| Stereotactic neurosurgery instruments - consumables | Z12100685 | I, IIa MDR | EUDAMED record Report an error | |
| Electroencephalography instruments - hardware accessories | Z12100380 | I, IIa MDR | EUDAMED record Report an error | |
| Somatosensory evoked potential integrated systems | Z12101103 | I, IIa MDR | EUDAMED record Report an error | |
| Stereotactic neurosurgery instruments - hardware accessories | Z12100680 | I MDR | EUDAMED record Report an error | |
| Peripheral or central neuro stimulation and assessment instruments - consumables | Z12101185 | I MDR | EUDAMED record Report an error | |
| Peripheral or central neuro stimulation and assessment instruments - hardware accessories | Z12101180 | IIa MDR | EUDAMED record Report an error | |
| Stereotactic neurosurgery instruments - software accessories | Z12100682 |
|
IIa MDR | EUDAMED record Report an error |
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