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LH Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref IM4403202Model IM4402202 IM4403202 IM4406202 IM4407202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM440202D2 Basic UDI-DIDate28 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  • Withdrawn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
LH Chemiluminescent Immunoassay Kit
Model / Reference
IM4402202 IM4403202 IM4406202 IM4407202, IM4403202
Primary DI / UDI-DI
06950617401247
Direct Marketing DI
06950617401247
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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