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Picterus® Jaundice Pro

by Picterus AS Norway EUDAMED

Ref 00028 EMDN Z12080492

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000231881 Date14 Apr 2025IssuedStatusExpiring expires 27 Oct 2026

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000231881 Supplemented Expires in 2 days

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    14 Apr 2025
    Expires
    27 Oct 2026
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
00028
Primary DI / UDI-DI
07073087000082
Basic UDI-DI
707308701PicterusL6
Direct Marketing DI
07073087000082
EMDN Code
Z12080492 Neonatology instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000002136

Other devices from Picterus AS

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f002e6c0-c5c2-44f9-9924-95ebc8da7d3a 61 fields · synced 22 Oct 2026