Manufacturer
Skanray
IndiaLegal entities : SKANRAY TECHNOLOGIES PRIVATE LIMITED
Markets : Belgium · United States
Approvals : EU – class IIb · United States (FDA) – 510(k) : 10 · class I, II · latest in 2025 · see on the FDA website
EU representative : SKANRAY EUROPE SRL (Italy)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Multi-parameter patient bedside monitors | Z1203020201 |
1 other
|
IIb 93/42 | EUDAMED record Report an error |
| Mobile radiographic units | Z11039016 | IIb MDR | EUDAMED record Report an error | |
| Pulmonary ventilators for hospital use - other | Z1203010599 |
|
IIb 93/42 | EUDAMED record Report an error |
| Anaesthesia devices | Z1203010101 | IIb 93/42 | EUDAMED record Report an error | |
| Anaesthesia systems - other | Z1203010199 |
|
IIb 93/42 | EUDAMED record Report an error |
| Equipment for digital endoral radiology | Z1103040102 | IIb MDR | EUDAMED record Report an error | |
| Mobile radioscopic units | Z11039017 |
|
IIb MDR | EUDAMED record Report an error |
| Multifunctional systems for direct digital radiology | Z11031101 | IIb 93/42 | EUDAMED record Report an error |
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