Identity
- Trade Name
- ELIOS EUDAMED
- Device Name
- ELIOS EUDAMED
- Model / Reference
- ELIOS EUDAMED8037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053847360129 EUDAMED
- Basic UDI-DI
- B-08053847360129 EUDAMED
- EMDN Code
- Z12080401,Z12080407 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elios by GINEVRI 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-08053847360129 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GINEVRI srl
- EUDAMED SRN
- IT-MF-000034527
Sources (1)
- EUDAMED 3d50c94e-76b5-4abe-b5f8-9cd2c8e5b604 61 fields · synced Jun 18, 2026