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Immunohistology Kits

by ScyTek Laboratories Inc. United States EUDAMED

Ref CPH080

EMDN W01030711

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081010871W01030711F5 Basic UDI-DIDate7 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Immunohistology Kits
Model / Reference
CPH080
Primary DI / UDI-DI
00810108715023
Basic UDI-DI
081010871W01030711F5
Direct Marketing DI
00810108715023
EMDN Code
W01030711 Immunohistology kits
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023816
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from ScyTek Laboratories Inc.

See all devices from ScyTek Laboratories Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED c5c03dc5-a816-4b33-aa18-1b5736ce759d 61 fields · synced 24 Oct 2026