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X-Ray FLAT PANEL IMAGER FDXA3543RP

EUDAMED

Class I (EU MDR)

Ref -Model X-ray Flat Panel Imager

by Canon Electron Tubes & Devices Co., Ltd.

Identity

Trade Name
X-Ray FLAT PANEL IMAGER FDXA3543RP EUDAMED
Model / Reference
X-ray Flat Panel Imager EUDAMED
- EUDAMED

Identifiers

Primary DI / UDI-DI
04580274419136 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 FDXA3543RP by Canon Electron Tubes & Devices Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
JP-MF-000009481
Authorised Representative
Canon Medical Components Europe B.V. NL-AR-000029305

Sources (1)

  • EUDAMED a062a5dc-6439-416a-8aa7-0f595fe3cc0b 61 fields · synced Aug 2, 2026