← Back to catalogue
cobas c 311 analyzer Language Pack 1.13.1.tr
EUDAMEDClass A (EU MDR)
Ref 09743596001Model cobas c 311 analyzer
Identity
- Trade Name
- cobas c 311 analyzer Language Pack 1.13.1.tr EUDAMED
- Device Name
- cobas c 311 analyzer Language Pack EUDAMED
- Model / Reference
- cobas c 311 analyzer EUDAMED09743596001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336217368 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.tr 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hitachi High-Tech Corporation
- EUDAMED SRN
- JP-MF-000016991
- Authorised Representative
- Roche Diagnostics GmbH DE-AR-000006262
Sources (1)
- EUDAMED 77011acc-b332-42a9-94b0-fbf2f55b6bcc 61 fields · synced Aug 2, 2026