Skip to content

SpotLight

by Arineta Israel EUDAMED

Ref 07290016484045 EMDN Z11020301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3903104CE01 Date14 Jul 2026IssuedStatusActive expires 1 Mar 2031

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  • Withdrawn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)
  • 3903104CE01 Amended

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    14 Jul 2026
    Expires
    1 Mar 2031
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SpotLight and CardioGraphe family of products
Model / Reference
07290016484045
Primary DI / UDI-DI
07290016484045
Basic UDI-DI
7290016484SLG5
Direct Marketing DI
07290016484045
EMDN Code
Z11020301 CT/pet systems
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000028266
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Arineta, Ltd.

See all devices from Arineta, Ltd. →

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 c8c51810-aaae-4ef7-83c7-ce74cab665ee 61 fields · synced 24 Oct 2026