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Nio
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K9300370B1XModel Radiology Display
by Barco NV
Identity
- Trade Name
- Nio EUDAMEDNio 5.8MP Gray FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- MDNC-6121, MDNG-6221, MDNC-12130 EUDAMEDMDNG-6221 SPEF FDA UDI
- Model / Reference
- Radiology Display EUDAMEDK9300370B1X EUDAMEDMDNG-6221 FDA UDI
- Description
- MDNG-6221 SPEF FDA UDI
Identifiers
- Catalog Number
- K9300370B1X FDA UDI
- Primary DI / UDI-DI
- 05415334044036 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 aafd816a-3ea9-42d1-876e-24f16c9867cd 61 fields · synced Jul 8, 2026
- FDA UDI e3e6f41f-c204-493b-acb1-e901ed442b4e 35 fields · synced May 30, 2026