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Labex Canada

by Labex Canada Inc. EUDAMED

Active European Union

Ref LC-FH20-R006Model 1mL

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number754016166FH20R0064M Basic UDI-DIDate22 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  • Withdrawn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

Device Name
DAPI solution
Model / Reference
1mL, LC-FH20-R006
Primary DI / UDI-DI
00628448120328
Direct Marketing DI
00628448120328
Market of Registration
Türkiye

Manufacturer details

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

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