← Back to catalogue
cobas pro integrated solutions Language Pack - Czech Version 2.3.cs
EUDAMEDClass A (EU MDR)
Ref 09956107001Model cobas pro integrated solutionsRef 09812113001
Identity
- Trade Name
- cobas pro integrated solutions Language Pack - Czech Version 2.3.cs EUDAMEDcobas pro integrated solutions Language Pack - Czech Version 2.3.1.cs EUDAMED
- Device Name
- cobas pro integrated solutions Language Pack Version 2.3.1 EUDAMED
- Model / Reference
- cobas pro integrated solutions EUDAMED09956107001 EUDAMED09812113001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336223918 EUDAMED07613336220597 EUDAMED
- Basic UDI-DI
- 761333602637B8 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 pro integrated solutions Language Pack - Czech Version 2.3.cs 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 | 761333602637B8 | 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 (2)
- EUDAMED 5c07dbca-08bc-400d-b92b-01af9c2b0972 61 fields · synced Jul 10, 2026
- EUDAMED d8214f63-f6a2-4772-b187-d5940c7fa490 61 fields · synced May 18, 2026