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KARL100 2.0

by Tema Sinergie S.p.a. Italy EUDAMED

Ref 135000054Model Automatic transportable dose fractionator

EMDN Z11029005

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8056351100000KARL2.0ZJ Basic UDI-DIDate29 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Karl 100 2.0
Model / Reference
Automatic transportable dose fractionator, 135000054
Primary DI / UDI-DI
08056351100120
Basic UDI-DI
8056351100000KARL2.0ZJ
Direct Marketing DI
08056351100120
EMDN Code
Z11029005 Automatic dose calibrators
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027196

Other devices from Tema Sinergie S.p.a.

See all devices from Tema Sinergie S.p.a. →

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 (1)

  • EUDAMED b52972fe-4a1c-4e96-a44c-26901e8b7d4e 61 fields · synced 22 Oct 2026