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Etanolifiksatiivi 50 % V/V, sis. eosiinia (120 x 10 ml)

by Reagena Oy

Ref 102354AModel 102354SC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number643007445102354SC77 Basic UDI-DI 06430074450588UDI-DIDate28 Apr 2022RegisteredStatusActive

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  • Withdrawn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
Ethanol fixative 50% V/V incl. eosin
Model / Reference
102354SC, 102354A
Primary DI / UDI-DI
06430074450588
Basic UDI-DI
643007445102354SC77
Unit of Use DI
06430074452605
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class A
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000002804

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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