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Laser Biopsy Cassettes - Red

EUDAMED

Class A (EU MDR)

Ref 210-12-10LMRef 215-12-10LMIRef 215-12-10LMRef 210-12-10LMI

by Shandon Diagnostics Limited

Identity

Trade Name
Laser Biopsy Cassettes - Red EUDAMED
Device Name
Embedding and Biopsy Cassettes EUDAMED
Model / Reference
210-12-10LM EUDAMED
215-12-10LMI EUDAMED
215-12-10LM EUDAMED
210-12-10LMI EUDAMED

Identifiers

Primary DI / UDI-DI
05051663625708 EUDAMED
05051663626545 EUDAMED
05051663625821 EUDAMED
05051663626422 EUDAMED
Basic UDI-DI
5051663SDL026KJ EUDAMED
Unit of Use DI
05051663628129 EUDAMED
05051663627399 EUDAMED
05051663628242 EUDAMED
05051663627276 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 - Red 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 e67c7914-fda7-4f9a-87a5-867640da77ee 61 fields · synced Aug 2, 2026
  • EUDAMED fbb345ff-5cd3-46e8-9346-69a2e2e4533b 61 fields · synced May 17, 2026
  • EUDAMED a9cc2ab4-bc0c-4f7f-b103-e3af6d490abb 61 fields · synced May 17, 2026
  • EUDAMED 571effab-cda3-4dee-b46a-2fcdf7b7a045 61 fields · synced May 17, 2026