Manufacturer
Remedi
South KoreaLegal entities : REMEDI Inc.
Markets : Germany · Italy · United States
Approvals : EU – class IIb · United States (FDA) – 510(k) : 5 · class II · latest in 2026 · see on the FDA website
EU representative : Javitech Consulting 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 |
|---|---|---|---|---|
| X-ray tube assembly | Z11039012 | IIb 93/42 | EUDAMED record Report an error | |
| Mobile radiographic units | Z11039016 |
|
IIb 93/42 | EUDAMED record Report an error |
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