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VEA Align
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref VEA Align
by EOS imaging
Identity
- Trade Name
- VEA Align EUDAMEDFDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- VEA Align EUDAMED
- Model / Reference
- VEA Align EUDAMED3.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663999000412 EUDAMEDFDA UDI
- Basic UDI-DI
- 3663999ALI01Y8 EUDAMED
- Direct Marketing DI
- 03663999000412 EUDAMED
- 510(k) Number
- K240582 FDA UDI
- FDA Product Code
- QIH FDA UDI
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VEA Align by Eos Imaging — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123740 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K120721 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K231917 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3663999ALI01Y8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- EOS imaging
- EUDAMED SRN
- FR-MF-000000502
Sources (3)
- EUDAMED 266129a5-aa82-4be7-8d6b-9d7e561c9a8a 61 fields · synced Jul 22, 2026
- FDA UDI c527bbbe-e37a-46a9-99de-fbcba515858e 33 fields · synced May 30, 2026
- FDA 510(k) K123740 1 fields · synced May 18, 2026