Manufacturer
Jpi
South KoreaLegal entities : JPI Healthcare Co., Ltd.
Markets : Italy · Netherlands · United States
Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 16 · class I, II · latest in 2026 · see on the FDA website
EU representative : Emergo Europe B.V. (Netherlands)
- 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 |
|---|---|---|---|---|
| Radiology instruments - other | Z11030599 | I MDR | EUDAMED record Report an error | |
| Multifunctional systems for direct digital radiology | Z11031101 | IIb MDR | EUDAMED record Report an error | |
| Radiology instruments - software accessories | Z11030582 | IIa MDR | EUDAMED record Report an error |
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