Skip to content

cobas 8000 modular analyzer series Language Pack - Chinese Version 6.10.zh

by Hitachi High-Tech Corporation

Ref 09976400001Model cobas 8000 modular analyzer 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333602778BT Basic UDI-DI 07613336224472UDI-DIDate17 Apr 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  • Withdrawn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 8000 modular analyzer series Language Pack - Version 6.10
Model / Reference
cobas 8000 modular analyzer series, 09976400001
Primary DI / UDI-DI
07613336224472
Basic UDI-DI
761333602778BT
EMDN Code
W0201010182, W0201020182
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