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Healthy Heart Check

by Vital Signs Solutions Ltd. EUDAMED

Active European Union

Ref FP0131Model Lipid Test CE Variant

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50700005359LIPIDHK Basic UDI-DIDate2 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1465400006 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 0483
    Issued
    25 Mar 2026
    Expires
    28 Feb 2030

Specification

EUDAMED

Device Name
PocDoc Lipid Self-Test
Model / Reference
Lipid Test CE Variant, FP0131
Primary DI / UDI-DI
05070000535920
Basic UDI-DI
50700005359LIPIDHK
Direct Marketing DI
05070000535920
EMDN Code
W01010215,W01010228,W01010231
Device Class
Class C
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000035287
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

  • Microbial Substances
  • Self Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No