Identity
- Trade Name
- BioCassette II EUDAMED
- Device Name
- Embedding cassettes EUDAMED
- Model / Reference
- 07-8120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033976235659 EUDAMED
- Basic UDI-DI
- 080339762W05030501YL EUDAMED
- EMDN Code
- W05030501 INCLUSION DEVICES, CASSETTES 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
BioCassette II 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 | 080339762W05030501YL | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (1)
- EUDAMED cab5a928-0ae2-44ee-b347-a5fb62e19c7c 61 fields · synced Jul 12, 2026