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cobas 8100 automated workflow series Language Pack - English Version 4.6.1.en
EUDAMEDClass A (EU MDR)
Ref 09857044001Model cobas 8100 automated workflow seriesRef 10716142001Ref 09506039018
Identity
- Trade Name
- cobas 8100 automated workflow series Language Pack - English Version 4.6.1.en EUDAMEDcobas 8100 automated workflow series Language Pack - English Version 4.11.en EUDAMEDcobas 8100 automated workflow series Language Pack - English Version 4.4.1.en EUDAMED
- Device Name
- cobas 8100 automated workflow series Language Pack Version 4.6.1 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.11 EUDAMEDcobas 8100 automated workflow series Language Pack Version 4.4.1. EUDAMED
- Model / Reference
- cobas 8100 automated workflow series EUDAMED09857044001 EUDAMED10716142001 EUDAMED09506039018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336222058 EUDAMED07613336243343 EUDAMED07613336203415 EUDAMED
- Basic UDI-DI
- 761333602692BG EUDAMED761333603408AW EUDAMED761333602197AZ 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 - English Version 4.6.1.en 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 761333602692BG | Class A | Active |
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Manufacturer
- Manufacturer
- Hitachi High-Tech Corporation
- EUDAMED SRN
- JP-MF-000016991
- Authorised Representative
- Roche Diagnostics GmbH DE-AR-000006262
Sources (3)
- EUDAMED 04e7d2f3-f655-47bb-b7c3-45485608994a 61 fields · synced Jul 30, 2026
- EUDAMED 43074cde-e42b-4a9a-8f83-119d65427a9c 61 fields · synced May 18, 2026
- EUDAMED a7b47ed7-c9f8-4a09-801c-907d2b313c7e 61 fields · synced May 18, 2026