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cobas i601 System Software version 01-05

by Roche Diagnostics GmbH Germany EUDAMED

Ref 10835290001

EMDN W0201010182

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333603524AZ Basic UDI-DIDate25 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
10835290001
Primary DI / UDI-DI
07613336245910
Basic UDI-DI
761333603524AZ
EMDN Code
W0201010182 Chemistry analysers - software accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006260

Other devices from Roche Diagnostics GmbH

See all devices from Roche Diagnostics GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • New Device
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 07613336245910|761333603524AZ 61 fields · synced 24 Oct 2026