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LUMEA BxChip

by Themis Pathology EUDAMED

Active European Union

Ref BxC 001.bModel LUMEA BxChip

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5944759003BXC001B0000006M Basic UDI-DIDate29 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sectionable Matrix for Biopsies NS
Model / Reference
LUMEA BxChip, BxC 001.b
Primary DI / UDI-DI
05944759003521
Basic UDI-DI
5944759003BXC001B0000006M
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000023578

Other devices from Themis Pathology

Properties

Other properties (11)

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