Identity
- Trade Name
- B-PRO450 Open EUDAMED
- Device Name
- Instruments for histopathology EUDAMED
- Model / Reference
- 40-100-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034120279376 EUDAMED
- Basic UDI-DI
- 080341202W0202059010M2 EUDAMED
- Direct Marketing DI
- 08034120279376 EUDAMED
- EMDN Code
- W0202059010 TISSUE PROCESSORS 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
Yes
EUDAMED
New Device
No
EUDAMED
B-PRO450 Open by Bio-Optica Milano S.p.A. — 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 | 080341202W0202059010M2 | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (1)
- EUDAMED cfb134cc-3b02-43aa-932c-ebffab72ee44 61 fields · synced Jun 18, 2026