Manufacturer
Brainnavi
TaiwanLegal entities : Brain Navi Biotechnology Co., Ltd.
Markets : Germany · United States
Approvals : EU – class I, IIb · United States (FDA) – 510(k) : 1 · class I, II · latest in 2025 · see on the FDA website
EU representative : MDSS GmbH (Germany)
- 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 systems | Z12100601 | I, IIb 93/42 | EUDAMED record Report an error | |
| Surgical navigation system | Z12011401 |
|
IIb 93/42 | EUDAMED record Report an error |
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