Identity
- Trade Name
- Bionet Cassettes - Ochre EUDAMED
- Device Name
- Embedding and Biopsy Cassettes EUDAMED
- Model / Reference
- 615-11-10LMI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663626781 EUDAMED
- Basic UDI-DI
- 5051663SDL026KJ EUDAMED
- Unit of Use DI
- 05051663627634 EUDAMED
- EMDN Code
- W05020106 BIOPSY CARTRIDGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Bionet Cassettes - Ochre by Shandon Diagnostics Limited — 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 | 5051663SDL026KJ | Class A | Active |
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Manufacturer
- Manufacturer
- Shandon Diagnostics Limited
- EUDAMED SRN
- GB-MF-000008187
- Authorised Representative
- Epredia Netherlands B.V. NL-AR-000001488
Sources (1)
- EUDAMED e2684831-4801-4ef8-b5b6-94cc94e0bde7 61 fields · synced Jun 19, 2026