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HSV-1/2 IgM Calibrators

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4282332

EMDN W0105080999

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-EIM4282332HQ Basic UDI-DIDate22 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
HSV-1/2 IgM Calibrators
Model / Reference
EIM4282332
Primary DI / UDI-DI
D-EIM4282332HQ
Basic UDI-DI
B-EIM4282332HQ
EMDN Code
W0105080999 Standards and calibrators - inf. immunology - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4e0979e1-5a69-4f3a-b35b-71cd2b59cd8d 61 fields · synced 22 Oct 2026