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cobas 8100 automated workflow series Language Pack - German Version 4.7.de

EUDAMED

Class A (EU MDR)

Ref 09985794001Model cobas 8100 automated workflow seriesRef 09857125001Ref 10716266001Ref 10107251001Ref 09506039003

by Hitachi High-Tech Corporation

Identity

Trade Name
cobas 8100 automated workflow series Language Pack - German Version 4.7.de EUDAMED
cobas 8100 automated workflow series Language Pack - German Version 4.6.1.de EUDAMED
cobas 8100 automated workflow series Language Pack - German Version 4.11.de EUDAMED
cobas 8100 automated workflow series Language Pack - German Version 4.8.de EUDAMED
cobas 8100 automated workflow series Language Pack - German Version 4.4.1.de EUDAMED
Device Name
cobas 8100 automated workflow series Language Pack Version 4.7 EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.6.1 EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.11 EUDAMED
cobas 8100 automated workflow series Language Packs Version 4.8 EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.4.1. EUDAMED
Model / Reference
cobas 8100 automated workflow series EUDAMED
09985794001 EUDAMED
09857125001 EUDAMED
10716266001 EUDAMED
10107251001 EUDAMED
09506039003 EUDAMED

Identifiers

Primary DI / UDI-DI
07613336224779 EUDAMED
07613336222102 EUDAMED
07613336243350 EUDAMED
07613336227756 EUDAMED
07613336203422 EUDAMED
Basic UDI-DI
761333602797BX EUDAMED
761333602692BG EUDAMED
761333603408AW EUDAMED
761333602930B9 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 - German Version 4.7.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

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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 78f494cc-fc6b-4cc1-a8b3-57af18c1772e 61 fields · synced Oct 6, 2026
  • EUDAMED 3ab7ba58-10f3-4e3b-8f31-a6d58089e670 61 fields · synced May 18, 2026
  • EUDAMED 778ffd0f-77e4-48b7-8355-b1d22f22ba66 61 fields · synced May 18, 2026
  • EUDAMED 594676de-a0b8-499f-b804-6058a4097777 61 fields · synced May 19, 2026
  • EUDAMED 0b7c6826-a04e-449d-a656-b6686a171441 61 fields · synced May 19, 2026