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Laser Embedding Cassettes - Ochre
EUDAMEDClass A (EU MDR)
Ref 110-11-10LMIRef 815-11-18LMIRef 115-11-10LMIRef 315-11-18LMIRef 815-11-18LM
Identity
- Trade Name
- Laser Embedding Cassettes - Ochre EUDAMED
- Device Name
- Embedding and Biopsy Cassettes EUDAMED
- Model / Reference
- 110-11-10LMI EUDAMED815-11-18LMI EUDAMED115-11-10LMI EUDAMED315-11-18LMI EUDAMED815-11-18LM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663626170 EUDAMED05051663626903 EUDAMED05051663626293 EUDAMED05051663626651 EUDAMED05051663626057 EUDAMED
- Basic UDI-DI
- 5051663SDL026KJ EUDAMED
- Unit of Use DI
- 05051663627023 EUDAMED05051663627757 EUDAMED05051663627146 EUDAMED05051663627504 EUDAMED05051663628471 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
Laser Embedding 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 (5)
- EUDAMED abd90900-8a2c-40e9-99ed-2b40e64456ff 61 fields · synced Jul 16, 2026
- EUDAMED a612e564-5a43-4f2f-b6ec-7810dfa3dee4 61 fields · synced May 17, 2026
- EUDAMED 9e290895-0b0b-4629-8126-172785f12767 61 fields · synced May 17, 2026
- EUDAMED e7b57f00-4182-4e9e-afcc-29cb3b2de3fd 61 fields · synced May 18, 2026
- EUDAMED f94ed633-2aff-486f-b29d-809104f62197 61 fields · synced May 18, 2026