Identity
- Trade Name
- SkanRevive+ EUDAMED
- Model / Reference
- SkanRevive+ EUDAMEDF3-18-390-0081-46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904269470064 EUDAMED
- Basic UDI-DI
- B-18904269470064 EUDAMED
- EMDN Code
- C020499 EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - 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
SkanRevive+ 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-18904269470064 | 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 184fb571-5bda-43bd-b972-ded771fa9f48 61 fields · synced Jul 18, 2026