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Laser Biopsy Cassettes - Ochre

EUDAMED

Class A (EU MDR)

Ref 215-11-10LMRef 210-11-10LMRef 215-11-10LMIRef 210-11-10LMI

by Shandon Diagnostics Limited

Identity

Trade Name
Laser Biopsy Cassettes - Ochre EUDAMED
Device Name
Embedding and Biopsy Cassettes EUDAMED
Model / Reference
215-11-10LM EUDAMED
210-11-10LM EUDAMED
215-11-10LMI EUDAMED
210-11-10LMI EUDAMED

Identifiers

Primary DI / UDI-DI
05051663625814 EUDAMED
05051663625692 EUDAMED
05051663626538 EUDAMED
05051663626415 EUDAMED
Basic UDI-DI
5051663SDL026KJ EUDAMED
Unit of Use DI
05051663628235 EUDAMED
05051663628112 EUDAMED
05051663627382 EUDAMED
05051663627269 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 - Ochre 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 75c09c25-52f2-4216-90c3-93c2e1fba005 61 fields · synced Jul 28, 2026
  • EUDAMED 61003db8-8be2-4dc3-9061-f96cc7d05f23 61 fields · synced May 16, 2026
  • EUDAMED 8c10a9d0-6fc3-4b42-9bfe-a74977847541 61 fields · synced May 16, 2026
  • EUDAMED b3b30cad-c45a-432d-95e6-5ae32c560fa2 61 fields · synced May 17, 2026