Identity
- Trade Name
- ROTANODE DRX-1824B EUDAMED
- Model / Reference
- X-ray Tube Assembly EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580274410157 EUDAMED
- Basic UDI-DI
- 45802744133523659295537M9 EUDAMED
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rotanode Drx-1824b by Canon Electron Tubes & Devices Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 45802744133523659295537M9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Canon Electron Tubes & Devices Co., Ltd.
- EUDAMED SRN
- JP-MF-000009481
- Authorised Representative
- Canon Medical Components Europe B.V. NL-AR-000029305
Sources (1)
- EUDAMED 4ba6660e-5d48-4038-8ec7-593a939c41b9 61 fields · synced Jul 26, 2026