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Xmark - Tissue Marking Dye - Black - 250ml Bottle

by CellPath Ltd 2 variants

Ref RCA-0101-00D

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 Number05056256RCA00144 Basic UDI-DI 05056256109689UDI-DIDate26 Jul 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  • Withdrawn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
XMark
Model / Reference
RCA-0101-00D
Primary DI / UDI-DI
05056256109689
Basic UDI-DI
05056256RCA00144
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000022744
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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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