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HSV-2 IgM Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4422125, IM4423125, IM4419125

EMDN W0105040310

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IM4422125J9 Basic UDI-DIDate22 May 2022RegisteredStatusActive

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 22 Oct 2026

Device Name
HSV-2 IgM Antibody Chemiluminescent Immunoassay Kit
Model / Reference
IM4422125, IM4423125, IM4419125
Primary DI / UDI-DI
D-IM4422125J9, D-IM4423125JG, D-IM4419125KF
Basic UDI-DI
B-IM4422125J9, B-IM4423125JG, B-IM4419125KF
EMDN Code
W0105040310 Hsv 2 igm
Device Class
Class IVD General
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
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (3)

  • EUDAMED 37a91d52-b15b-47ca-a681-df70cae7526e 61 fields · synced 22 Oct 2026
  • EUDAMED 50b642e1-ba0c-4e91-91c9-340c57d3c576 61 fields · synced 16 May 2026
  • EUDAMED 24692b65-b239-4350-9716-77a42cb1d321 61 fields · synced 19 May 2026