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CCM Bidirectional Unit
EUDAMEDClass A (EU MDR)
Ref 09511717001Model ATU-PVT-AC5
Identity
- Trade Name
- CCM Bidirectional Unit EUDAMED
- Device Name
- CCM Bidirectional Unit EUDAMED
- Model / Reference
- ATU-PVT-AC5 EUDAMED09511717001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336202241 EUDAMED
- Basic UDI-DI
- 7613336022029Z EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER 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
Yes
EUDAMED
New Device
No
EUDAMED
CCM Bidirectional Unit by Hitachi, Ltd. — 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 | 7613336022029Z | Class A | Active |
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Manufacturer
- Manufacturer
- Hitachi, Ltd.
- EUDAMED SRN
- JP-MF-000018582
- Authorised Representative
- Roche Diagnostics GmbH DE-AR-000006262
Sources (1)
- EUDAMED c25a5b5f-17d3-47a3-b39a-49f8a2e4a6f9 61 fields · synced Jul 14, 2026