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Karl 100 2.0 System

by Tema Sinergie S.p.A. Italy EUDAMED

Ref 135000059Model Portable Automatic Dose Dispensing System EMDN Z11029005

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8056351100000KARL2.0SYSPL Basic UDI-DIDate23 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Portable Automatic Dose Dispensing System, 135000059
Primary DI / UDI-DI
08056351100137
Basic UDI-DI
8056351100000KARL2.0SYSPL
EMDN Code
Z11029005 Automatic dose calibrators
Device Class
Class IIb
Medical Purpose
The transportable automatic fractionation system (Karl 100 2.0 System) is a medical system for the safe storage and protection of operators of the FDG radiopharmaceutical ([18F]-fluorodeoxyglucose) and, associated with a dose calibrator, manages the measurement of the fractionation by placing the radiopharmaceutical with the necessary level of activity in a syringe.

Manufacturer details

EUDAMED SRN
IT-PR-000038767

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 4b06e8e6-892d-481f-93a5-ef8236303726 61 fields · synced 22 Oct 2026