Identity
- Device Name
- VOYAGER EUDAMED
- Model / Reference
- VA3540-BB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056479540105 EUDAMED
- Basic UDI-DI
- B-08056479540105 EUDAMED
- EMDN Code
- K020399 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Voyager by Alfamed Srl — 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-08056479540105 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alfamed Srl
- EUDAMED SRN
- IT-MF-000033580
Sources (1)
- EUDAMED 0c57f1cf-218e-423f-b90e-bd00a574797f 61 fields · synced Jun 20, 2026