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Afinion Lipid Panel

by Abbott Diagnostics Technologies AS 2 variants

Ref 1116802

Expiring European Union

CE IVDR

Valid until

4 Jul 2027

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIVDR 738185 Date18 Sep 2026IssuedStatusExpiring expires 4 Jul 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 738185 Expiring Supplemented Expires in 246 days

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    18 Sep 2026
    Expires
    4 Jul 2027
    Reason
    Change approved

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Expiring

Specification

EUDAMED

Device Name
Afinion ACR Control
Model / Reference
1116802
Primary DI / UDI-DI
07070060014074
Basic UDI-DI
7070060LIP0001DA
EMDN Code
W0101060401 Multiple enzymes &/or substrates &/or electrolytes
Device Class
Class B
EU market of registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000001423

Other devices from Abbott Diagnostics Technologies AS

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No