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Flat Panel Detector Ar-C4343w
EUDAMEDClass I (EU MDR)
Ref BT8-1911Model FLAT PANEL DETECTOR
by Canon Inc.
Identity
- Trade Name
- FLAT PANEL DETECTOR AR-C4343W EUDAMED
- Device Name
- AR-D1 EUDAMED
- Model / Reference
- FLAT PANEL DETECTOR EUDAMEDBT8-1911 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04549292175653 EUDAMED
- Basic UDI-DI
- 4549292fp01CY EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class I 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
Category: Stationary basic diagnostic x-ray system, digital
Flat Panel Detector Ar-C4343w by Canon Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4549292fp01CY | Class I | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- EUDAMED SRN
- JP-MF-000013254
- Authorised Representative
- Canon Medical Components Europe B.V. NL-AR-000029305
Sources (1)
- EUDAMED 3dc48b4e-76f5-4818-bc28-c4df2c32c87d 61 fields · synced Jun 19, 2026