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Barco
EUDAMEDFDA UDIClass I (EU MDR)
Ref 600301479Model Nexxis OR, Nexxis 2.xx
by Barco NV
Identity
- Trade Name
- Barco EUDAMEDFDA 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, NMS 2.xx, MNA-420 ENC ANA EUDAMEDVANTAGEVIEW 2.0 ENCODER 4K FDA UDI
- Model / Reference
- Nexxis OR, Nexxis 2.xx EUDAMED600301479 EUDAMEDMNA-440 FDA UDI
- Description
- VANTAGEVIEW 2.0 ENCODER 4K FDA UDI
Identifiers
- Catalog Number
- 600301479 FDA UDI
- Primary DI / UDI-DI
- 05415334053458 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
Barco 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 7f2a7ab4-e510-4d73-9ae7-104b6aadcbe4 61 fields · synced Sep 17, 2026
- FDA UDI c7ad1e14-51ce-4de2-8903-09d25f88ff99 36 fields · synced May 30, 2026