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cobas c 311 analyzer Language Pack 1.13.1.pt
EUDAMEDClass A (EU MDR)
Ref 09465537001Model cobas c 311 analyzer
Identity
- Trade Name
- cobas c 311 analyzer Language Pack 1.13.1.pt EUDAMED
- Device Name
- cobas c 311 analyzer Language Pack EUDAMED
- Model / Reference
- cobas c 311 analyzer EUDAMED09465537001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336188583 EUDAMED
- Basic UDI-DI
- 761333601997C2 EUDAMED
- EMDN Code
- W0201010182 CHEMISTRY ANALYSERS - 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 c 311 analyzer Language Pack 1.13.1.pt by Hitachi High-Tech Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 761333601997C2 | 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 (1)
- EUDAMED 0d2ff284-a2ee-4f06-9cd6-1e0b0336dba4 61 fields · synced Jul 18, 2026