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Transport Belt 3 (w/o ISE)

by Hitachi High-Tech Corporation

Ref 05990017001Model 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7613336014009Y Basic UDI-DI 04015630943685UDI-DIDate9 Feb 2022RegisteredStatusActive

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  • Withdrawn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

Model / Reference
cobas 8000 modular analyzer series, 05990017001
Primary DI / UDI-DI
04015630943685
Basic UDI-DI
7613336014009Y
EMDN Code
W02010399 Integrated / modular chemistry / immunochemistry instruments - other
Device Class
Class A
EU 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