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cobas 8000 modular analyzer series Language Pack - English Version 6.9.1.en
EUDAMEDClass A (EU MDR)
Ref 09720162001Model cobas 8000 modular analyzer seriesRef 09432086001Ref 09976299001
Identity
- Trade Name
- cobas 8000 modular analyzer series Language Pack - English Version 6.9.1.en EUDAMEDcobas 8000 modular analyzer series Language Pack-English EUDAMEDcobas 8000 modular analyzer series Language Pack - English Version 6.10.en EUDAMED
- Device Name
- cobas 8000 modular analyzer series Language Pack Version 6.9.1 EUDAMEDcobas 8000 modular analyzer series Language Pack EUDAMEDcobas 8000 modular analyzer series Language Pack - Version 6.10 EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED09720162001 EUDAMED09432086001 EUDAMED09976299001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336215937 EUDAMED07613336187142 EUDAMED07613336224410 EUDAMED
- Basic UDI-DI
- 761333602638BA EUDAMED761333601994BU EUDAMED761333602778BT EUDAMED
- EMDN Code
- W0201010182,W0201020182 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 8000 modular analyzer series Language Pack - English Version 6.9.1.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 | 761333602638BA | 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 e7eab09b-cc63-4353-89a0-759a0b0ae5f2 61 fields · synced Sep 18, 2026
- EUDAMED 8f45ff3c-6260-479a-ae46-992fe8f280da 61 fields · synced May 17, 2026
- EUDAMED 8c156d75-719c-49bb-9603-30d31588916f 61 fields · synced May 17, 2026