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Borelli

by Biosynex France EUDAMED

Ref BORELT18, BORELPC18Model BORELLI EMDN W0104030405

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00118P85 Basic UDI-DIDate18 May 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
BORELLI, BORELT18, BORELPC18
Primary DI / UDI-DI
03532678594644, 03532678594668
Basic UDI-DI
353267F00118P85
Unit of Use DI
03532670102762, 03532670102618
EMDN Code
W0104030405 Identification systems for yeasts and fungi - manual
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

See all devices from Biosynex →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED d9174c51-f69e-40fb-a154-cf25d2cd7b79 61 fields · synced 24 Oct 2026
  • EUDAMED 03532678594668|353267F00118P85 61 fields · synced 17 May 2026