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cobas 8000 modular analyzer series Language Pack - Chinese Version 6.9.1.zh

EUDAMED

Class A (EU MDR)

Ref 09720073001Model cobas 8000 modular analyzer seriesRef 09976400001

by Hitachi High-Tech Corporation

Identity

Trade Name
cobas 8000 modular analyzer series Language Pack - Chinese Version 6.9.1.zh EUDAMED
cobas 8000 modular analyzer series Language Pack - Chinese Version 6.10.zh EUDAMED
Device Name
cobas 8000 modular analyzer series Language Pack Version 6.9.1 EUDAMED
cobas 8000 modular analyzer series Language Pack - Version 6.10 EUDAMED
Model / Reference
cobas 8000 modular analyzer series EUDAMED
09720073001 EUDAMED
09976400001 EUDAMED

Identifiers

Primary DI / UDI-DI
07613336215852 EUDAMED
07613336224472 EUDAMED
Basic UDI-DI
761333602638BA EUDAMED
761333602778BT 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 - Chinese Version 6.9.1.zh 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

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Manufacturer

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

Sources (2)

  • EUDAMED 5d8a7def-c648-4533-8107-a6e9b5b3de1e 61 fields · synced Jul 19, 2026
  • EUDAMED 1f8ccdcc-3514-442b-9eef-95b1a472c42e 61 fields · synced May 18, 2026