Manufacturer
Carestream Health
United StatesLegal entities : Carestream Health, Inc.
Markets : France · Italy · Netherlands · United States
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 53 · PMA : 2 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : Italy 2 · France 1
EU representative : CARESTREAM HEALTH ITALIA S.R.L. (Italy)
- 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 |
|---|---|---|---|---|
| Mobile radiographic units | Z11039016 | IIb MDR | EUDAMED record Report an error | |
| Systems for direct digital radiology (dr) - hardware accessories | Z11031180 |
|
IIa MDR | EUDAMED record Report an error |
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