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cobas 8100 automated workflow series Language Pack - French Version 4.6.1.fr

EUDAMED

Class A (EU MDR)

Ref 09857052001Model cobas 8100 automated workflow seriesRef 09985751001Ref 10716282001Ref 10652888001Ref 09506039080

by Hitachi High-Tech Corporation

Identity

Trade Name
cobas 8100 automated workflow series Language Pack - French Version 4.6.1.fr EUDAMED
cobas 8100 automated workflow series Language Pack - French Version 4.7.fr EUDAMED
cobas 8100 automated workflow series Language Pack - French Version 4.11.fr EUDAMED
cobas 8100 automated workflow series Language Pack - French Version 4.10.fr EUDAMED
cobas 8100 automated workflow series Language Pack - French Version 4.4.1.fr EUDAMED
Device Name
cobas 8100 automated workflow series Language Pack Version 4.6.1 EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.7 EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.11 EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.10 EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.4.1. EUDAMED
Model / Reference
cobas 8100 automated workflow series EUDAMED
09857052001 EUDAMED
09985751001 EUDAMED
10716282001 EUDAMED
10652888001 EUDAMED
09506039080 EUDAMED

Identifiers

Primary DI / UDI-DI
07613336222065 EUDAMED
07613336224731 EUDAMED
07613336243374 EUDAMED
07613336241752 EUDAMED
07613336203446 EUDAMED
Basic UDI-DI
761333602692BG EUDAMED
761333602797BX EUDAMED
761333603408AW EUDAMED
761333603362AX EUDAMED
761333602197AZ EUDAMED
EMDN Code
W02069082 VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES 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 8100 automated workflow series Language Pack - French Version 4.6.1.fr 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 (5)

  • EUDAMED 7a7e5dfb-7f99-4cda-b43f-15539d1fd0ac 61 fields · synced Jul 14, 2026
  • EUDAMED ce14fbcc-fc9b-4bfc-b53e-2470c35e8196 61 fields · synced May 17, 2026
  • EUDAMED 65d8d642-1dfd-488e-8c37-d0d104b1d9c8 61 fields · synced May 18, 2026
  • EUDAMED f6a8f8c0-bfad-4aad-be23-63803690e75f 61 fields · synced May 18, 2026
  • EUDAMED cbeb0ba4-303c-4739-87e7-650c1611e40d 61 fields · synced May 19, 2026