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MP Diagnostics HIV Ag/Ab Combo ELISA 4.0

by MP Biomedicals Asia Pacific Pte Ltd EUDAMED

Active European Union

Ref 23040-096

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08887581002126 Basic UDI-DIDate10 Apr 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
23040-096
Primary DI / UDI-DI
08887581002126
Basic UDI-DI
B-08887581002126
EMDN Code
W0105030404 HIV multiple ag/ab combi test
Device Class
Class IVD Annex II List A
Market of Registration
Germany

Manufacturer details

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

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Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No