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QAWeb Enterprise
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K5402921Model Medical calibration and QA SW
by Barco NV
Identity
- Trade Name
- QAWeb Enterprise EUDAMEDFDA UDI
- Generic Name
- Radiology workstation display quality assurance software FDA UDI
- Device Name
- QAWeb Enterprise EUDAMEDQAWeb Enterprise Agent FDA UDI
- Model / Reference
- Medical calibration and QA SW EUDAMEDK5402921 EUDAMEDV2.xx FDA UDI
- Description
- QAWeb Enterprise Agent FDA UDI
Identifiers
- Catalog Number
- K5402921 FDA UDI
- Primary DI / UDI-DI
- 05415334002432 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_QAWeb_D3 EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology workstation display quality assurance software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
QAWeb Enterprise by Barco NV — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5415334_QAWeb_D3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (2)
- EUDAMED 0d189f91-bd76-48e0-9f08-78957b9c9689 61 fields · synced Sep 18, 2026
- FDA UDI 6e091e95-ad8a-4a67-ba7c-3d48ecc7ef8d 35 fields · synced May 30, 2026