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MP Diagnostics HBsAg ELISA 4.1

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

Ref 23470-480Model 23470-480 (480 wells) EMDN W0105090201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08887581001006 Basic UDI-DIDate13 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
23470-480 (480 wells), 23470-480
Primary DI / UDI-DI
08887581001006
Basic UDI-DI
B-08887581001006
EMDN Code
W0105090201 Hbsag - rt & poc
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

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
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 36f8abc7-e767-421b-ac41-d6fc1be226ee 61 fields · synced 24 Oct 2026