Skip to content

cobas 8100 automated workflow series Language Pack - Italian Version 4.7.it

by Hitachi High-Tech Corporation

Ref 09985778001Model cobas 8100 automated workflow series

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333602797BX Basic UDI-DI 07613336224755UDI-DIDate3 Aug 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
cobas 8100 automated workflow series Language Pack Version 4.7
Model / Reference
cobas 8100 automated workflow series, 09985778001
Primary DI / UDI-DI
07613336224755
Basic UDI-DI
761333602797BX
EMDN Code
W02069082 Various sample processing instruments - software accessories
Device Class
Class A
Special Device Type
Software
EU 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

See all devices from Hitachi High-Tech Corporation →

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