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Cholesterol Control

by Helena Biosciences Europe United Kingdom EUDAMED

Ref 3218

EMDN W01010205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05056013011897 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
3218
Primary DI / UDI-DI
05056013011897
Basic UDI-DI
B-05056013011897
EMDN Code
W01010205 Cholesterol
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000028365
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Helena Biosciences Europe

See all devices from Helena Biosciences Europe →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 2ccb6670-85b1-4e20-9b1f-ea2a4e4ee4d4 61 fields · synced 24 Oct 2026