Identity
- Trade Name
- ArtPix Mobile EZ2GO EUDAMEDArtPiX Mobile EZ2GO FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- ArtPix Mobile EZ2GO EUDAMED
- Model / Reference
- 62833765 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701440100172 EUDAMEDFDA UDI
- Basic UDI-DI
- 37014401042B EUDAMED
- Direct Marketing DI
- 03701440100172 EUDAMED
- FDA Product Code
- KPR FDA UDIMQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Stationary basic diagnostic x-ray system, digital
ArtPix Mobile EZ2GO by Thales Avs France Sas — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37014401042B | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Thales Avs France Sas
- EUDAMED SRN
- FR-MF-000012704
Sources (2)
- EUDAMED 452ba820-ad04-4a84-8037-b0fe0c2fc111 61 fields · synced Jul 19, 2026
- FDA UDI fe007e1d-ee4e-4dc5-a754-6e5055961d68 32 fields · synced May 30, 2026