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Labex Canada

by Labex Canada Inc. Canada EUDAMED

Ref LCR-0283-06Model Ready to use 6mL

EMDN W01030709

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00628448120908 Basic UDI-DIDate23 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
HBsAg Mouse Monoclonal Antibody
Model / Reference
Ready to use 6mL, LCR-0283-06
Primary DI / UDI-DI
00628448120908
Basic UDI-DI
B-00628448120908
EMDN Code
W01030709 Primary antisera for immunohistology
Device Class
Class IVD General
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 (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f4af02d1-2db0-4865-9b7a-482eb3b90e0e 61 fields · synced 23 Oct 2026