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Formalin 10 % (800 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde

by Reagena Oy

Ref 102256C8Model 102256

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 Number643007445102256A2 Basic UDI-DI 06430074450809UDI-DIDate1 Feb 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  • Withdrawn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
Formalin 10 %, phosphate buffered pH 7,2 incl. 4 % formaldehyde
Model / Reference
102256, 102256C8
Primary DI / UDI-DI
06430074450809
Basic UDI-DI
643007445102256A2
Direct Marketing DI
06430074450809
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