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cobas e 411 analyzer Language Pack – German Version 3.2.1.de

by Hitachi High-Tech Corporation Japan EUDAMED

Ref 09313893001Model cobas e 411 analyzer

EMDN W0201020182

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7613336020049T Basic UDI-DIDate8 Feb 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
cobas e 411 analyzer Language Pack
Model / Reference
cobas e 411 analyzer, 09313893001
Primary DI / UDI-DI
07613336191217
Basic UDI-DI
7613336020049T
EMDN Code
W0201020182 Automated immunochemistry analysers - software accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000016991
Authorised representative
Roche Diagnostics GmbH DE-AR-000006262

Other devices from Hitachi High-Tech Corporation

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • 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
  • New Device: No

Sources (1)

  • EUDAMED d7e1398a-288a-4109-9cd8-f64d58fc9919 61 fields · synced 22 Oct 2026