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HAV IgM Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4291315

EMDN W0105080902

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IM4291315KU Basic UDI-DIDate22 May 2022RegisteredStatusActive
European UnionCE/IVDR NumberB-IM4291315KU Basic UDI-DIDate22 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
HAV IgM Control
Model / Reference
IM4291315
Primary DI / UDI-DI
D-IM4291315KU, 06950617419747
Basic UDI-DI
B-IM4291315KU, 69506174IM429315ER
Direct Marketing DI
06950617419747
EMDN Code
W0105080902, W0105080899
Device Class
Class IVD General
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 4946beba-0668-432c-b0f2-172c9799506e 61 fields · synced 22 Oct 2026
  • EUDAMED 06950617419747|69506174IM429315ER 61 fields · synced 17 May 2026