← Back to catalogue
cobas pro B-Gate Upgrade Kit
EUDAMEDClass A (EU MDR)
Ref 09205756001Model cobas pro integrated solutions
Identity
- Trade Name
- cobas pro B-Gate Upgrade Kit EUDAMED
- Device Name
- cobas pro B-Gate Upgrade Kit EUDAMED
- Model / Reference
- cobas pro integrated solutions EUDAMED09205756001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336179574 EUDAMED
- Basic UDI-DI
- 761333601780B7 EUDAMED
- EMDN Code
- W0201010180,W0201020180 EUDAMED
Classification
- Device Class
- Class A 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 B-Gate Upgrade Kit 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 | 761333601780B7 | 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 40092fcf-2e5c-42dd-ba9e-4c0c203d37c9 61 fields · synced Jul 12, 2026