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10% saline Formalin - ready to use solution

by Bio-Optica Milano S.p.A. Italy EUDAMED

Ref 05-01020QModel Fixatives, decalcifiers, formalin prefilled

EMDN W01030705

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number080339762W01030705X2 Basic UDI-DIDate4 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Fixatives, decalcifier, formalin prefilled
Model / Reference
Fixatives, decalcifiers, formalin prefilled, 05-01020Q
Primary DI / UDI-DI
08033976231705
Basic UDI-DI
080339762W01030705X2
Direct Marketing DI
08033976231705
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027525

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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 cabfce11-c5e8-41c2-b217-e5431ec7e739 61 fields · synced 22 Oct 2026