Manufacturer
Alpinion
South KoreaLegal entities : Alpinion Medical Systems Co.,Ltd.
Markets : Germany · Poland · United States
Approvals : EU – class IIa · United States (FDA) – 510(k) : 26 · class II · latest in 2023 · see on the FDA website
EU representative : Alpinion Medical Deutschland 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 |
|---|---|---|---|---|
| Multidisciplinary ultrasound scanners (internal and cardiology, etc.) | Z11040104 | IIa MDR | EUDAMED record Report an error | |
| Portable ultrasound scanners | Z11040103 |
|
IIa MDR | EUDAMED record Report an error |
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