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V8 Haemoglobin UltraScreen Kit

by Helena Biosciences Europe United Kingdom EUDAMED

Ref 801100 EMDN W0103010202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05056013021575 Basic UDI-DIDate5 Oct 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  • Withdrawn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
801100
Primary DI / UDI-DI
05056013021575
Basic UDI-DI
B-05056013021575
EMDN Code
W0103010202 Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000028365
Authorised representative
Prince Technologies NL-AR-000006614

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 05056013021575|B-05056013021575 61 fields · synced 24 Oct 2026