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Flat Panel Detector Af-B1
EUDAMEDClass I (EU MDR)
Ref BT8-2240Model FLAT PANEL DETECTOR
by Canon Inc.
Identity
- Trade Name
- FLAT PANEL DETECTOR AF-B1 EUDAMED
- Device Name
- AR-D1 EUDAMED
- Model / Reference
- FLAT PANEL DETECTOR EUDAMEDBT8-2240 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04549292202960 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
Flat Panel Detector Af-B1 by Canon Inc. — Class I — 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 | 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 b6e06db1-cde8-4318-ad85-0527b6f0da67 61 fields · synced Jul 14, 2026