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Laser Embedding Cassettes - Aqua

EUDAMED

Class A (EU MDR)

Ref 815-08-18LMRef 115-08-10LMIRef 115-08-10LMRef 815-08-18LMI

by Shandon Diagnostics Limited

Identity

Trade Name
Laser Embedding Cassettes - Aqua EUDAMED
Device Name
Embedding and Biopsy Cassettes EUDAMED
Model / Reference
815-08-18LM EUDAMED
115-08-10LMI EUDAMED
115-08-10LM EUDAMED
815-08-18LMI EUDAMED

Identifiers

Primary DI / UDI-DI
05051663626026 EUDAMED
05051663626262 EUDAMED
05051663625548 EUDAMED
05051663626873 EUDAMED
Basic UDI-DI
5051663SDL026KJ EUDAMED
Unit of Use DI
05051663628440 EUDAMED
05051663627115 EUDAMED
05051663627962 EUDAMED
05051663627726 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 - 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

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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 f4df0715-32dc-4c1a-80ce-3534c4b47a99 61 fields · synced Jul 22, 2026
  • EUDAMED 095da8bd-75bf-46f4-86bb-452e5c8d0bf3 61 fields · synced May 17, 2026
  • EUDAMED d1504d32-bc2f-407f-a70c-5aef509960c4 61 fields · synced May 17, 2026
  • EUDAMED 10695a9f-6ad2-4be9-82ef-ebacbdeee13a 61 fields · synced May 18, 2026