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Laser Embedding Cassettes - Blue
EUDAMEDClass A (EU MDR)
Ref 815-03-18LMIRef 115-03-10LMIRef 115-03-10LMRef 315-03-18LM
Identity
- Trade Name
- Laser Embedding Cassettes - Blue EUDAMED
- Device Name
- Embedding and Biopsy Cassettes EUDAMED
- Model / Reference
- 815-03-18LMI EUDAMED115-03-10LMI EUDAMED115-03-10LM EUDAMED315-03-18LM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663626828 EUDAMED05051663626217 EUDAMED05051663625494 EUDAMED05051663625852 EUDAMED
- Basic UDI-DI
- 5051663SDL026KJ EUDAMED
- Unit of Use DI
- 05051663627672 EUDAMED05051663627061 EUDAMED05051663627917 EUDAMED05051663628273 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 - Blue 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 (4)
- EUDAMED ee4e8d5c-d8ad-47fd-8905-ca0827b2d842 61 fields · synced Aug 2, 2026
- EUDAMED 43c322b3-dd25-4033-b685-73f018c38993 61 fields · synced May 17, 2026
- EUDAMED bb6f3bc6-2c00-4263-98da-bdf62303a5e9 61 fields · synced May 18, 2026
- EUDAMED f81c3d5e-dfa8-4a86-a601-d02cf2d280e6 61 fields · synced May 19, 2026