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MP Diagnostics ASSURE H. pylori Rapid Test

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

Ref 43490-020 EMDN W0105090102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08887581000740 Basic UDI-DIDate2 Jul 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  • Withdrawn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 24 Oct 2026

Model / Reference
43490-020
Primary DI / UDI-DI
08887581000740
Basic UDI-DI
B-08887581000740
EMDN Code
W0105090102 H. pylori - rt & poc
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
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 08887581000740|B-08887581000740 61 fields · synced 24 Oct 2026