Identity
- Trade Name
- PIXIUM STATIC EUDAMED
- Device Name
- PIXIUM RAD 4343 EUDAMED
- Model / Reference
- PIXIUM RAD 4343 C-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701440100080 EUDAMED
- Basic UDI-DI
- 370144010125 EUDAMED
- Direct Marketing DI
- 03701440100080 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 | 370144010125 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Thales Avs France Sas
- EUDAMED SRN
- FR-MF-000012704
Sources (1)
- EUDAMED 79700519-6f93-45d4-8fc6-ca3b9f61105f 61 fields · synced Jun 18, 2026