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Formalin

by Proteome United Kingdom EUDAMED

Ref BCFZN500

EMDN W01030708

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5065019541AAA000K9 Basic UDI-DIDate2 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Formalin
Model / Reference
BCFZN500
Primary DI / UDI-DI
05065019541109
Basic UDI-DI
5065019541AAA000K9
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
UK-MF-000039824
Authorised representative
Propath bv BE-AR-000039586

Other devices from Proteome

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 452f4f57-2295-4c04-9d26-a6f3d0c0122c 61 fields · synced 24 Oct 2026