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PRE-FILLED CONTAINER 10% NEUTRAL BUFFERED FORMALIN RTU WHIT SCREWCAP 60 ML (40 ML) 35 PCS x 01 PACK

by Diapath S.p.A. società a socio unico

Ref Q01022Model GENERAL FIXATIVE - 10% NEUTRAL BUFFERED FORMALIN

Active European Union

CE IVDR

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8033895W01030705For10%RZ Basic UDI-DI 08033895009249UDI-DIDate27 Mar 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  • Withdrawn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

Device name
10% Neutral Buffered Formalin
Model / reference
GENERAL FIXATIVE - 10% NEUTRAL BUFFERED FORMALIN, Q01022
Primary DI / UDI-DI
08033895009249
Basic UDI-DI
8033895W01030705For10%RZ
Direct marketing DI
08033895009249
EMDN code
W01030705 Fixing reagents (histology/cytology)
Device class
Class A
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027016

From the manufacturer

Manufacturer's product page: Prefilled containers

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Properties

  • Reagent
  • Professional testing

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains substances of microbial origin: No
  • IVD kit: No
  • Self-testing: No
  • Near-patient testing: No
  • Companion diagnostics: No
  • IVD instrument: No
  • New device: No