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cobas 8100 automated workflow series Language Pack - Portuguese Version 4.10.pt

by Hitachi High-Tech Corporation EUDAMED

Active European Union

Ref 10652870001Model cobas 8100 automated workflow series

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333603362AX Basic UDI-DIDate24 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
cobas 8100 automated workflow series Language Pack Version 4.10
Model / Reference
cobas 8100 automated workflow series, 10652870001
Primary DI / UDI-DI
07613336241745
Basic UDI-DI
761333603362AX
EMDN Code
W02069082 Various sample processing instruments - 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

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Properties

  • 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