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Laser Embedding Cassettes - Orange
EUDAMEDClass A (EU MDR)
Ref 815-06-18LMIRef 110-06-10LMIRef 815-06-18LMRef 115-06-10LMRef 115-06-10LMIRef 315-06-18LM
Identity
- Trade Name
- Laser Embedding Cassettes - Orange EUDAMED
- Device Name
- Embedding and Biopsy Cassettes EUDAMED
- Model / Reference
- 815-06-18LMI EUDAMED110-06-10LMI EUDAMED815-06-18LM EUDAMED115-06-10LM EUDAMED115-06-10LMI EUDAMED315-06-18LM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663626859 EUDAMED05051663626125 EUDAMED05051663626002 EUDAMED05051663625524 EUDAMED05051663626248 EUDAMED05051663625883 EUDAMED
- Basic UDI-DI
- 5051663SDL026KJ EUDAMED
- Unit of Use DI
- 05051663627702 EUDAMED05051663626972 EUDAMED05051663628426 EUDAMED05051663627948 EUDAMED05051663627092 EUDAMED05051663628303 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 - Orange 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 (6)
- EUDAMED 03df1b74-af38-4cc3-919b-c7b6fb645a12 61 fields · synced Aug 1, 2026
- EUDAMED b7dcac8d-0151-4044-aae3-dda2bc693d75 61 fields · synced May 18, 2026
- EUDAMED 7ab830cd-5bde-47b6-8cb0-1da271245470 61 fields · synced May 18, 2026
- EUDAMED 5e2df752-57de-49f8-9481-f0b13fd3c779 61 fields · synced May 18, 2026
- EUDAMED 70e898b0-4be9-410d-800a-0983fcb3aa7b 61 fields · synced May 19, 2026
- EUDAMED 51aa0421-6631-4fdc-9cb4-80ca2ecc5902 61 fields · synced May 19, 2026