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Nio
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K9300394A1XModel Radiology DisplayRef K9300344BRef K9300371ARef K9301130ARef K9300381A1XRef K9300830A2XRef K9300381A
by Barco NV
Identity
- Trade Name
- Nio EUDAMEDNio Color 3MP FDA UDINio Color 8MP FDA UDINio Fusion 12MP FDA UDINio Color 2MP FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- MDNC-2123, MDNC-3521, MDNC-3421 EUDAMEDMDNC-6121, MDNG-6221, MDNC-12130 EUDAMEDMDCC-4430, MDCC-6530, MDNC-2521, MDNC-8132, MDNC-2221 EUDAMEDMDNC-3521 SPES DE FDA UDIMDNC-8132 SNES FDA UDIMDNC-12130 NC FDA UDIMDNC-2521 SNES FDA UDI
- Model / Reference
- Radiology Display EUDAMEDK9300394A1X EUDAMEDK9300344B EUDAMEDK9300371A EUDAMEDK9301130A EUDAMEDK9300381A1X EUDAMEDK9300830A2X EUDAMEDK9300381A EUDAMEDMDNC-3521 FDA UDIMDNC-8132 FDA UDIMDNC-12130 FDA UDIMDNC-2521 FDA UDI
- Description
- MDNC-3521 SPES DE FDA UDIMDNC-8132 SNES FDA UDIMDNC-12130 NC FDA UDIMDNC-2521 SNES FDA UDI
Identifiers
- Catalog Number
- K9300394A1X FDA UDIK9300830A2X FDA UDIK9301130A FDA UDIK9300381A1X FDA UDIK9300381A FDA UDI
- Primary DI / UDI-DI
- 05415334043732 EUDAMEDFDA UDI05415334028340 EUDAMED05415334042216 EUDAMED05415334044456 EUDAMEDFDA UDI05415334028425 EUDAMEDFDA UDI05415334043763 EUDAMEDFDA UDI05415334032873 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Dental_9N EUDAMED5415334_Tomo_KW EUDAMED5415334_Radiology_PX 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_Dental_9N | 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 (12)
- EUDAMED bceafda1-37b6-482b-8139-ca3c07928e39 61 fields · synced Sep 18, 2026
- EUDAMED 3bfecd92-4510-4a82-877f-cf84926db2b3 61 fields · synced May 18, 2026
- EUDAMED 6335da38-b4e1-4a83-8d21-bcd8010a177d 61 fields · synced May 18, 2026
- FDA UDI b8e1a67c-427b-4c34-bb27-44f55fc5992a 35 fields · synced May 27, 2026
- FDA UDI 7924fec3-f257-4f81-92b5-15962baf9636 35 fields · synced May 30, 2026
- FDA UDI 92666490-6a7f-4609-96a2-cce289f3f3ca 35 fields · synced May 30, 2026
- FDA UDI f6f0af06-5fe3-4989-b70d-cd79887d8d72 35 fields · synced May 30, 2026
- FDA UDI 54308f79-e909-4364-be80-11fee5ec2279 35 fields · synced May 30, 2026
- EUDAMED d266782e-beb9-4ffa-b3c9-38a1ee65037b 61 fields · synced Jul 13, 2026
- EUDAMED 7d90f412-4476-41ef-af6e-7aa463664d3d 61 fields · synced Jul 16, 2026
- EUDAMED a12f03ba-442e-4191-8efd-0dd9b5284e00 61 fields · synced Jul 22, 2026
- EUDAMED d3d46822-767a-4443-8a6c-8fef735a9a83 61 fields · synced Jul 24, 2026