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Nexxis OR
EUDAMEDFDA UDIClass I (EU MDR)
Ref K9350202IModel Nexxis ORRef K9303300DRef K9303321DRef K9303311D
by Barco NV
Identity
- Trade Name
- Nexxis OR 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 EUDAMEDMNA-420 DEC HDMI V2 INC SFP+ CN FDA UDI
- Model / Reference
- Nexxis OR EUDAMEDK9350202I EUDAMEDK9303300D EUDAMEDK9303321D EUDAMEDK9303311D EUDAMEDMNA-420 FDA UDI
- Description
- MNA-420 DEC HDMI V2 INC SFP+ CN FDA UDI
Identifiers
- Catalog Number
- K9350202I FDA UDI
- Primary DI / UDI-DI
- 05415334034815 EUDAMEDFDA UDI05415334037670 EUDAMED05415334037649 EUDAMED05415334037694 EUDAMED
- 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 (5)
- EUDAMED cba1336c-e8f6-4769-8385-babf81b3db2e 61 fields · synced Jul 19, 2026
- EUDAMED 36536097-c306-4409-8d0d-0a4d01b851a7 61 fields · synced May 17, 2026
- EUDAMED 68dda0ce-e9e1-445b-9f2e-93d0c4739320 61 fields · synced May 17, 2026
- EUDAMED bbac7979-e6ce-4382-aa75-af34d77dfa6a 61 fields · synced May 18, 2026
- FDA UDI 7f8daf93-f56a-44d2-9e6e-31d7974a8493 36 fields · synced May 30, 2026