Identity
- Trade Name
- PIXIUM STATIC EUDAMED
- Device Name
- PIXIUM PORTABLE EZ X EUDAMED
- Model / Reference
- PIXIUM PORTABLE 3543 EZ-C X D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701440100592 EUDAMED
- Basic UDI-DI
- 37014401092M EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Pixium Static by Thales Avs France Sas — Class IIa — 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 | 37014401092M | Class IIa | Active |
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Manufacturer
- Manufacturer
- Thales Avs France Sas
- EUDAMED SRN
- FR-MF-000012704
Sources (1)
- EUDAMED 5ac5fa51-05cf-45e8-b2f2-d0a851ce9afe 61 fields · synced Jun 18, 2026