Identity
- Trade Name
- Elafast® EUDAMED
- Device Name
- Elafast® EUDAMED
- Model / Reference
- 9191EP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08028169208411 EUDAMED
- Basic UDI-DI
- 802816920BW01020608053R EUDAMED
- EMDN Code
- W0102069009 ELASTASE (PANCREATIC POLYPEPTIDE) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Elafast® by Eurospital Spa — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 802816920BW01020608053R | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eurospital Spa
- EUDAMED SRN
- IT-MF-000028468
Sources (1)
- EUDAMED 0ef6afd4-bd33-4f2b-845d-167a5fc36c8b 61 fields · synced Jun 20, 2026