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Laser Embedding Cassettes - Pink

by Shandon Diagnostics Limited 8 variants

Ref 315-04-18LMI

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5051663SDL026KJ Basic UDI-DI 05051663626583UDI-DIDate12 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Embedding and Biopsy Cassettes
Model / Reference
315-04-18LMI
Primary DI / UDI-DI
05051663626583
Basic UDI-DI
5051663SDL026KJ
Unit of Use DI
05051663627436
EMDN Code
W05020106 Biopsy cartridges
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000008187
Authorised representative
Epredia Netherlands B.V. NL-AR-000001488

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Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No