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Q Fix 10% Buffered Neutral Formalin

by biocyc Biotechnologie GmbH & Co. KG 3 variants

Ref FX-001-5000

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42555978FIXATIONDF Basic UDI-DI 04255597800458UDI-DIDate12 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
fixation solution
Model / Reference
FX-001-5000
Primary DI / UDI-DI
04255597800458
Basic UDI-DI
42555978FIXATIONDF, 42555978FIXATIONFX001HG
Direct Marketing DI
04255597800458
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031533

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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