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Labex Canada

by Labex Canada Inc. Canada EUDAMED

Ref LC-AS88-R001Model 100tests/box EMDN W01030711

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number754016166AS88R001CD Basic UDI-DIDate7 Apr 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  • Withdrawn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
DAB detection system (LC-AS88 Stainer)
Model / Reference
100tests/box, LC-AS88-R001
Primary DI / UDI-DI
00628448120533
Basic UDI-DI
754016166AS88R001CD
Direct Marketing DI
00628448120533
EMDN Code
W01030711 Immunohistology kits
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

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

Related devices

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Other devices from Labex Canada Inc.

See all devices from Labex Canada Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 0ade2a92-d171-4321-b144-5d745bf7a8d0 61 fields · synced 23 Oct 2026