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Nexxis OR
EUDAMEDFDA UDIClass I (EU MDR)
Ref K9303320Model 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-420 ENC HDMI FDA UDI
- Model / Reference
- Nexxis OR EUDAMEDK9303320 EUDAMEDMNA-420 FDA UDI
- Description
- MNA-420 ENC HDMI FDA UDI
Identifiers
- Catalog Number
- K9303320 FDA UDI
- Primary DI / UDI-DI
- 05415334002364 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_NexxisOR_P4 EUDAMED
- 510(k) Number
- K173381 FDA UDI
- 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
- 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 — 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_NexxisOR_P4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (2)
- EUDAMED 26023b4e-0154-4500-94c2-183d26925c5e 61 fields · synced May 31, 2026
- FDA UDI a859e2f7-4f28-443f-9a2a-c578781f4b72 36 fields · synced May 29, 2026