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Q Fix 10% Buffered Neutral Formalin

by biocyc Biotechnologie GmbH & Co. KG EUDAMED

Active European Union

Ref FX-001-1000

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42555978FIXATIONDF Basic UDI-DIDate12 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
fixation solution
Model / Reference
FX-001-1000
Primary DI / UDI-DI
04255597800434
Basic UDI-DI
42555978FIXATIONDF, 42555978FIXATIONFX001HG
Direct Marketing DI
04255597800434
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031533

Other devices from biocyc Biotechnologie GmbH & Co. KG

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Properties

  • 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