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Papanicolaou’s solution 2a Orange G solution (OG6) for cytology

by Merck KGaA 2 variants

Ref 1068881022, 1068882500, 1068881000

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 Number4027269106888WE Basic UDI-DI Date17 Apr 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  • Withdrawn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
1068881022, 1068882500, 1068881000
Primary DI / UDI-DI
04022536707365, 04022536084169, 04022536676579
Basic UDI-DI
4027269106888WE
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000018777

Other devices from Merck KGaA

See all devices from Merck KGaA →

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