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Nio 5.8MP Gray
EUDAMEDClass IIa (EU MDR)
Ref K9300375C1XModel Radiology Display
by Barco NV
Identity
- Trade Name
- Nio 5.8MP Gray EUDAMED
- Device Name
- MDNC-6121, MDNG-6221, MDNC-12130 EUDAMED
- Model / Reference
- Radiology Display EUDAMEDK9300375C1X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415334060159 EUDAMED
- Basic UDI-DI
- 5415334_Tomo_KW EUDAMED
- EMDN Code
- Z11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Nio 5.8MP Gray by Barco NV — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5415334_Tomo_KW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (1)
- EUDAMED 47ca4dbe-97f8-49a5-ad10-b62ccd84b89e 61 fields · synced Jul 12, 2026