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Gold Chloride Solution (0.2%) 30 mL

by ScyTek Laboratories Inc. EUDAMED

Active European Union

Ref GCB030

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081010871W01030708FG Basic UDI-DIDate31 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Stain Solutions
Model / Reference
GCB030
Primary DI / UDI-DI
00850075153503
Basic UDI-DI
081010871W01030708FG
Direct Marketing DI
00850075153503
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023816
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