ArtPix Mobile EZ2GO
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- ArtPix Mobile EZ2GO EUDAMEDArtPiX Mobile EZ2GO FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Static imaging solutions EUDAMED
- Model / Reference
- 62833765 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290012104602 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290012104026Y EUDAMED
- Direct Marketing DI
- 07290012104602 EUDAMED
- 510(k) Number
- K162224 FDA UDI
- FDA Product Code
- KPR 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
- Germany 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 CMT Medical Technologies, Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162224 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 7290012104026Y | Class IIb | Active |
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Manufacturer
- Manufacturer
- CMT Medical Technologies, Ltd.
- EUDAMED SRN
- IL-MF-000017569
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 77ea1f2f-d679-499d-aa15-230d9028dca9 85 fields · synced Jun 18, 2026
- FDA UDI a9280d4f-5f3f-4881-9667-bce559c85944 33 fields · synced May 30, 2026
- FDA 510(k) K162224 1 fields · synced May 18, 2026