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cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2 +…

EUDAMED

Class A (EU MDR)

Ref 09440208001Model cobas c 513 analyzer

by Hitachi High-Tech Corporation

Identity

Trade Name
cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1 EUDAMED
Device Name
cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1 EUDAMED
Model / Reference
cobas c 513 analyzer EUDAMED
09440208001 EUDAMED

Identifiers

Primary DI / UDI-DI
07613336187739 EUDAMED
Basic UDI-DI
761333602156AK EUDAMED
EMDN Code
W0201010182 CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES EUDAMED
Models / Variants
cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2 EUDAMED
5 EUDAMED
1 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 c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2 +… by Hitachi High-Tech Corporation — Class A — IVDR — listed in EUDAMED — 3…

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 (1)

  • EUDAMED a938fd1d-ac8a-4b40-9c94-d224002513d5 61 fields · synced Jun 18, 2026