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Labex Canada

by Labex Canada Inc. Canada EUDAMED

Ref LC-AS88-R004Model 1L, Concentrated (10×)

EMDN W01030799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number754016166AS88R004CK Basic UDI-DIDate7 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Epitope retrieval solution (pH 9.0)
Model / Reference
1L, Concentrated (10×), LC-AS88-R004
Primary DI / UDI-DI
00628448120502
Basic UDI-DI
754016166AS88R004CK
Direct Marketing DI
00628448120502
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

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

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 13599305-dee2-4159-baab-38a11788dc6a 61 fields · synced 22 Oct 2026