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X-Ray FLAT PANEL IMAGER FDXA3543RPS
EUDAMEDClass I (EU MDR)
Ref -Model X-ray Flat Panel Imager
Identity
- Trade Name
- X-Ray FLAT PANEL IMAGER FDXA3543RPS EUDAMED
- Model / Reference
- X-ray Flat Panel Imager EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580274419174 EUDAMED
- Basic UDI-DI
- 45802744125364940471340LB EUDAMED
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Electromagnetic surgical navigation device tracking system
X-Ray FLAT PANEL IMAGER FDXA3543RPS by Canon Electron Tubes & Devices Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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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 | 45802744125364940471340LB | Class I | 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 355a6fc8-8cb6-47a4-9167-7a7547f379e3 61 fields · synced Jul 15, 2026