Manufacturer
Leltek
TaiwanLegal entities : Leltek Inc.
Markets : Germany · United States
Approvals : EU – class IIa · United States (FDA) – 510(k) : 5 · class II · latest in 2025 · see on the FDA website
EU representative : MedNet EC-REP 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 |
|---|---|---|---|---|
| Handheld ultrasound scanners | Z11040106 |
|
IIa MDR, 93/42 | EUDAMED record Report an error |
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