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Dilute Carbol Fuchsin concentrate (100ml)

by Pro-Lab Diagnostics UK

Ref PL.8004Model 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 Number506047246GramStainsFA Basic UDI-DI 50604724615448UDI-DIDate8 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  • Withdrawn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
Gram Stains
Model / Reference
Stains, PL.8004
Primary DI / UDI-DI
50604724615448
Basic UDI-DI
506047246GramStainsFA
Direct Marketing DI
50604724615448
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