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cobas 8000 modular analyzer series Language Pack - Portuguese Version 6.10.pt
EUDAMEDClass A (EU MDR)
Ref 09976361001Model cobas 8000 modular analyzer seriesRef 09432175001Ref 09720111001
Identity
- Trade Name
- cobas 8000 modular analyzer series Language Pack - Portuguese Version 6.10.pt EUDAMEDcobas 8000 modular analyzer series Language Pack-Portuguese EUDAMEDcobas 8000 modular analyzer series Language Pack - Portuguese Version 6.9.1.pt EUDAMED
- Device Name
- cobas 8000 modular analyzer series Language Pack - Version 6.10 EUDAMEDcobas 8000 modular analyzer series Language Pack EUDAMEDcobas 8000 modular analyzer series Language Pack Version 6.9.1 EUDAMED
- Model / Reference
- cobas 8000 modular analyzer series EUDAMED09976361001 EUDAMED09432175001 EUDAMED09720111001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336224458 EUDAMED07613336187203 EUDAMED07613336215883 EUDAMED
- Basic UDI-DI
- 761333602778BT EUDAMED761333601994BU EUDAMED761333602638BA 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 - Portuguese Version 6.10.pt 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 | 761333602778BT | 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 0362f3ae-3c97-48df-a06b-909851601797 61 fields · synced Oct 6, 2026
- EUDAMED 3d711ff4-6fbc-4810-8281-73c7e9a2a578 61 fields · synced May 19, 2026
- EUDAMED 913067bb-4394-47b6-bbae-050da169f0a7 61 fields · synced May 19, 2026