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MP Diagnostics Helico Blot 2.1

by MP Biomedicals Asia Pacific Pte Ltd United States EUDAMED

Ref 12420-036 EMDN W0105010402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08887581000269 Basic UDI-DIDate26 Aug 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  • Withdrawn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

Device Name
MP Diagnostic Helico Blot 2.1
Model / Reference
12420-036
Primary DI / UDI-DI
08887581000269
Basic UDI-DI
B-08887581000269
EMDN Code
W0105010402 H. pylori antibody assays
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
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 90d2209e-e586-4fff-866e-3fc6e41bfe03 61 fields · synced 24 Oct 2026