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cobas 8100 automated workflow series Language Pack – Italian Version 4.4.1.it

EUDAMED

Class A (EU MDR)

Ref 09505881001Model cobas 8100 automated workflow seriesRef 10652861001Ref 09857087001Ref 09985778001Ref 10716304001

by Hitachi High-Tech Corporation

Identity

Trade Name
cobas 8100 automated workflow series Language Pack – Italian Version 4.4.1.it EUDAMED
cobas 8100 automated workflow series Language Pack - Italian Version 4.10.it EUDAMED
cobas 8100 automated workflow series Language Pack - Italian Version 4.6.1.it EUDAMED
cobas 8100 automated workflow series Language Pack - Italian Version 4.7.it EUDAMED
cobas 8100 automated workflow series Language Pack - Italian Version 4.11.it EUDAMED
Device Name
cobas 8100 automated workflow series Language Pack Version 4.4.1. EUDAMED
cobas 8100 automated workflow series Language Pack Version 4.10 EUDAMED
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
Model / Reference
cobas 8100 automated workflow series EUDAMED
09505881001 EUDAMED
10652861001 EUDAMED
09857087001 EUDAMED
09985778001 EUDAMED
10716304001 EUDAMED

Identifiers

Primary DI / UDI-DI
07613336203453 EUDAMED
07613336241738 EUDAMED
07613336222089 EUDAMED
07613336224755 EUDAMED
07613336243381 EUDAMED
Basic UDI-DI
761333602197AZ EUDAMED
761333603362AX EUDAMED
761333602692BG EUDAMED
761333602797BX EUDAMED
761333603408AW 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 – Italian Version 4.4.1.it 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 99f4496b-d1da-45f0-a42f-680ca7cd921b 61 fields · synced Jul 18, 2026
  • EUDAMED 78f1f2c3-1cb0-45db-b569-48650c220857 61 fields · synced May 18, 2026
  • EUDAMED 19fcc2a6-1c98-45af-aa93-34d585b1991d 61 fields · synced May 18, 2026
  • EUDAMED ba240433-1fd0-431e-a09f-164bad769b22 61 fields · synced May 18, 2026
  • EUDAMED ee76037f-8532-40a1-a350-fae96969a050 61 fields · synced May 19, 2026