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Labex Canada

by Labex Canada Inc. Canada EUDAMED

Ref LC-FH20 EMDN W0202059099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number754016166FH207E Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Automatic Fluorescence in Situ (FISH) Hybridizer
Model / Reference
LC-FH20
Primary DI / UDI-DI
00628448120366
Basic UDI-DI
754016166FH207E
Direct Marketing DI
00628448120366
EMDN Code
W0202059099 Various processing instruments for hystology / cytology - other
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CA-MF-000039965
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Labex Canada Inc.

See all devices from Labex Canada Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED ae3f1bbe-e67d-4803-be80-e3892f5b270f 61 fields · synced 23 Oct 2026