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Nexxis OR
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref K9303053AModel Nexxis OR
by Barco NV
Identity
- Trade Name
- Nexxis OR EUDAMEDNexxis FDA UDI
- Generic Name
- Operating room audiovisual data/device management system FDA UDI
- Device Name
- MNA-120, MNA-240, MNA-420, MNA-440, NMS 1.18 EUDAMEDMNA-120 ENC DP AUDIO KS FDA UDI
- Model / Reference
- Nexxis OR EUDAMEDK9303053A EUDAMEDMNA-120 FDA UDI
- Description
- MNA-120 ENC DP AUDIO KS FDA UDI
Identifiers
- Catalog Number
- K9303053A FDA UDI
- Primary DI / UDI-DI
- 05415334000711 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_NexxisOR_P4 EUDAMED
- FDA Product Code
- DXJ FDA UDI
- EMDN Code
- Z11069099 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Operating room audiovisual data/device management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2450 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
Nexxis OR by Barco NV — Class I — 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
United States Active
FDA_510K
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 | K173381 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K170537 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K122167 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5415334_NexxisOR_P4 | Class I | Active |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (3)
- EUDAMED 3169db3d-8577-4382-b6a8-0e5ed092a2bb 61 fields · synced Jul 18, 2026
- FDA UDI c0d5528f-ae27-4d9f-a786-55809fa1716e 36 fields · synced May 30, 2026
- FDA 510(k) K173381 1 fields · synced May 18, 2026