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Coronis Uniti
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref K9301401A2XModel Radiology Display
by Barco NV
Identity
- Trade Name
- Coronis Uniti EUDAMEDCoronis OneLook FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- MDMC-32133 EUDAMEDMDMC-32133 E FDA UDI
- Model / Reference
- Radiology Display EUDAMEDK9301401A2X EUDAMEDMDMC-32133 FDA UDI
- Description
- MDMC-32133 E FDA UDI
Identifiers
- Catalog Number
- K9301401A2X FDA UDI
- Primary DI / UDI-DI
- 05415334046511 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Multimodality_SA EUDAMED
- FDA Product Code
- PGY FDA UDI
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Coronis Uniti by Barco NV — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151505 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5415334_Multimodality_SA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (3)
- EUDAMED 6e0e429a-999f-4af3-af44-38a75e69f10c 61 fields · synced Jun 19, 2026
- FDA UDI a63a5b87-c1dc-4378-8c5f-ecb8c9abf3c9 35 fields · synced May 30, 2026
- FDA 510(k) K151505 1 fields · synced May 18, 2026