Identity
- Device Name
- FRAS Bravo EUDAMED
- Model / Reference
- FRASB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050247770015 EUDAMED
- Basic UDI-DI
- 805024777FRASB9S EUDAMED
- EMDN Code
- W0201010299 LIMITED PANEL CHEMISTRY ANALYSERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
FRAS Bravo by H & D S.r.l. — Class A — 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 | 805024777FRASB9S | Class A | Active |
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Manufacturer
- Manufacturer
- H & D S.r.l.
- EUDAMED SRN
- IT-MF-000036620
Sources (1)
- EUDAMED f851de75-11be-41db-b566-9ced77ea263e 61 fields · synced Jul 29, 2026