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Differentiator for ZN & Kinyoun Carbol Fuchsin (2000ml)

by Pro-Lab Diagnostics UK

Ref PL.7026Model Stains

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 Number506047246AFBStainsSH Basic UDI-DI 50604724604480UDI-DIDate11 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  • Withdrawn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

Device Name
Acid-Fast Stains
Model / Reference
Stains, PL.7026
Primary DI / UDI-DI
50604724604480
Basic UDI-DI
506047246AFBStainsSH
Direct Marketing DI
50604724604480
EMDN Code
W0104010804 Stains
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000003833
Authorised representative
Advena Limited MT-AR-000000234

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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