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Kopernikus

by tic Medizintechnik GmbH Germany EUDAMED

Ref ti1950Model Newton / Kopernikus / Cassini

EMDN U0599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426021766-D-NewKopCasK7 Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Newton - urological function diagnostics
Model / Reference
Newton / Kopernikus / Cassini, ti1950
Primary DI / UDI-DI
04260217669247
Basic UDI-DI
426021766-D-NewKopCasK7
Direct Marketing DI
04260217669247
EMDN Code
U0599 Urodynamics devices - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000033923

Other devices from tic Medizintechnik GmbH

See all devices from tic Medizintechnik GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
  • Measuring Function
Other properties (11)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 3180a0fe-af96-4741-94d9-9800a54d4025 61 fields · synced 24 Oct 2026