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Labax Canada

by Labex Canada Inc. Canada EUDAMED

Ref LC-U-R003Model 5mL, 100mL, 1L

EMDN W01030710

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number754016166UR0038B Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

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
Super Sensitive Universal HRP-Polymer IHC Detection Kit
Model / Reference
5mL, 100mL, 1L, LC-U-R003
Primary DI / UDI-DI
00628448120212
Basic UDI-DI
754016166UR0038B
Direct Marketing DI
00628448120212
EMDN Code
W01030710 Secondary antisera for immunohistology
Device Class
Class A
Market of Registration
Türkiye

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
  • 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 3e7f65b9-9b5c-4cce-ae34-305e56a947df 61 fields · synced 24 Oct 2026