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Nio
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K9301130A2XModel Radiology Display
by Barco NV
Identity
- Trade Name
- Nio EUDAMEDNio Fusion 12MP FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- MDNC-6121, MDNG-6221, MDNC-12130 EUDAMEDMDNC-12130 FDA UDI
- Model / Reference
- Radiology Display EUDAMEDK9301130A2X EUDAMEDMDNC-12130 FDA UDI
- Description
- MDNC-12130 FDA UDI
Identifiers
- Catalog Number
- K9301130A2X FDA UDI
- Primary DI / UDI-DI
- 05415334044357 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Tomo_KW 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
Nio 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_Tomo_KW | 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 b9a9403f-62f5-41af-a7ec-5a9d33c9f52c 61 fields · synced May 30, 2026
- FDA UDI b2e8bcfb-e0fe-4376-bd09-6c67744939e2 35 fields · synced May 30, 2026