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MP Diagnostics HEV lgM ELISA 3.0

by MP Biomedicals Asia Pacific Pte Ltd FDA registration: Singapore EUDAMED

Ref 23160-096 EMDN W0105020505

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08887581000535 Basic UDI-DIDate21 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
23160-096
Primary DI / UDI-DI
08887581000535
Basic UDI-DI
B-08887581000535
EMDN Code
W0105020505 Hev antibody igm
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000024819
Authorised representative
MP Biomedicals Germany GmbH DE-AR-000020992

Other devices from MP Biomedicals Asia Pacific Pte Ltd

See all devices from MP Biomedicals Asia Pacific Pte Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b859ec9d-9c33-4b8d-a16e-fb4c352d594e 61 fields · synced 22 Oct 2026