Identity
- Trade Name
- SkanRespiro EUDAMED
- Model / Reference
- SkanRespiro EUDAMEDF3-75-390-0192-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904269462205 EUDAMED
- Basic UDI-DI
- B-18904269462205 EUDAMED
- EMDN Code
- Z1203010599 PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SkanRespiro by Skanray Technologies Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18904269462205 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Skanray Technologies Limited
- EUDAMED SRN
- IN-MF-000034819
- Authorised Representative
- SKANRAY EUROPE SRL IT-AR-000013034
Sources (1)
- EUDAMED a062d0f6-f6da-42fe-b966-fef2c65276b0 61 fields · synced Jul 12, 2026