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CarimasCE

by The wellbeing services county of Southwest Finland Finland EUDAMED

Ref 1.3.9, 1.3.8

EMDN Z11020492

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number64382700001PJ Basic UDI-DIDate24 Apr 2025RegisteredStatusActive
European UnionCE/MDR Number64382700001PJ Basic UDI-DIDate24 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
1.3.9, 1.3.8
Primary DI / UDI-DI
06438270000002
Basic UDI-DI
64382700001PJ, B-06438270000002
EMDN Code
Z11020492 Positron emission tomography instruments - medical device software
Device Class
Class IIb
Class IIa
Special Device Type
Software
-1192
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000038025

Other devices from The wellbeing services county of Southwest Finland

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 0682c112-5775-484b-bf86-c4a2e3e69b51 61 fields · synced 22 Oct 2026
  • EUDAMED 06438270000002|B-06438270000002 61 fields · synced 17 May 2026