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Doctrin Source

by Doctrin AB EUDAMED

Active European Union

Ref SOURCE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number28620226787-01 Date6 Oct 2026IssuedStatusActive expires 27 Feb 2030

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  • Withdrawn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)
  • 28620226787-01 Amended

    Quality management system EU MDR

    Notified body
    Intertek Medical Notified Body AB 2862
    Issued
    6 Oct 2026
    Expires
    27 Feb 2030
    Reason
    Mnf data change

Specification

EUDAMED

Model / Reference
SOURCE
Primary DI / UDI-DI
07350174580000
Basic UDI-DI
735017458SOURCEN3
Direct Marketing DI
07350174580000
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000043089

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No