← Back to catalogue

cobas 8000 modular analyzer series Language Pack - German Version 6.10.de

EUDAMED

Class A (EU MDR)

Ref 09976264001Model cobas 8000 modular analyzer seriesRef 09432094001

by Hitachi High-Tech Corporation

Identity

Trade Name
cobas 8000 modular analyzer series Language Pack - German Version 6.10.de EUDAMED
cobas 8000 modular analyzer series Language Pack-German EUDAMED
Device Name
cobas 8000 modular analyzer series Language Pack - Version 6.10 EUDAMED
cobas 8000 modular analyzer series Language Pack EUDAMED
Model / Reference
cobas 8000 modular analyzer series EUDAMED
09976264001 EUDAMED
09432094001 EUDAMED

Identifiers

Primary DI / UDI-DI
07613336224403 EUDAMED
07613336187159 EUDAMED
Basic UDI-DI
761333602778BT EUDAMED
761333601994BU EUDAMED
EMDN Code
W0201010182,W0201020182 EUDAMED

Classification

Device Class
Class A EUDAMED
Special Device Type
Software EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

cobas 8000 modular analyzer series Language Pack - German Version 6.10.de by Hitachi High-Tech Corporation — Class A — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hitachi High-Tech Corporation
EUDAMED SRN
JP-MF-000016991
Authorised Representative
Roche Diagnostics GmbH DE-AR-000006262

Sources (2)

  • EUDAMED 3b811c9d-4376-49e8-b673-5f6083082027 61 fields · synced Jul 16, 2026
  • EUDAMED 3725416d-96b3-4775-a398-8ceee4f51b36 61 fields · synced May 18, 2026