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Laser Biopsy Cassettes - Aqua
EUDAMEDClass A (EU MDR)
Ref 215-08-10LMRef 210-08-10LMIRef 215-08-10LMI
Identity
- Trade Name
- Laser Biopsy Cassettes - Aqua EUDAMED
- Device Name
- Embedding and Biopsy Cassettes EUDAMED
- Model / Reference
- 215-08-10LM EUDAMED210-08-10LMI EUDAMED215-08-10LMI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663625784 EUDAMED05051663626385 EUDAMED05051663626507 EUDAMED
- Basic UDI-DI
- 5051663SDL026KJ EUDAMED
- Unit of Use DI
- 05051663628204 EUDAMED05051663627238 EUDAMED05051663627351 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 Biopsy Cassettes - Aqua 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 (3)
- EUDAMED c4b49dac-9d7c-47ec-898f-9652f46bdf2a 61 fields · synced Jul 14, 2026
- EUDAMED 783e7b2c-33a5-4556-881d-9c977314a111 61 fields · synced May 17, 2026
- EUDAMED 4479414e-11e7-4537-bdb7-ff1aee2331c4 61 fields · synced May 18, 2026