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๐˜๐˜ฆ๐˜ญ๐˜ช๐˜ค๐˜ฐ๐˜ฃ๐˜ข๐˜ค๐˜ต๐˜ฆ๐˜ณ ๐˜ฑ๐˜บ๐˜ญ๐˜ฐ๐˜ณ๐˜ช IgG

by Biohit Oyj Finland EUDAMED

Ref 601040.02

EMDN W0105010402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06419587010403 Basic UDI-DIDate21 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union โ€” CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED ยท synced 22 Oct 2026

Model / Reference
601040.02
Primary DI / UDI-DI
06419587010403
Basic UDI-DI
B-06419587010403
EMDN Code
W0105010402 H. pylori antibody assays
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000014642

Other devices from Biohit Oyj

See all devices from Biohit Oyj โ†’

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 0c982a8c-b7cc-42ac-8d79-9ca1a94477d1 61 fields ยท synced 22 Oct 2026