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cobas pure integrated solutions Instrument Software Version 01-02
EUDAMEDClass A (EU MDR)
Ref 09458115001Model cobas pure integrated solutions
Identity
- Trade Name
- cobas pure integrated solutions Instrument Software Version 01-02 EUDAMED
- Device Name
- cobas pure integrated solutions Instrument Software Version 01-02 EUDAMED
- Model / Reference
- cobas pure integrated solutions EUDAMED09458115001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336188248 EUDAMED
- Basic UDI-DI
- 761333602155AH 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 pure integrated solutions Instrument Software Version 01-02 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 | 761333602155AH | 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 cfdc74c4-29a1-46e8-94dd-e7d58b3104ca 61 fields · synced Oct 6, 2026