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Alcoholic Formalin 10%

by Atom Scientific Ltd 4 variants

Ref RRFF9000-EModel Cytology Fixative Solution

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 Number505591470RRFFEK Basic UDI-DI 05055914753042UDI-DIDate27 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Cytology Fixative Solution, RRFF9000-E
Primary DI / UDI-DI
05055914753042
Basic UDI-DI
505591470RRFFEK
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class A
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000046578
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Atom Scientific Ltd

See all devices from Atom Scientific Ltd →

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