Barco MCC-300
by Barco, Inc. EUDAMEDGUDID
Active
Ref K9351300Model Nexxis OR, Nexxis 2.xx
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number05415334059931 | Date21 Sep 2026 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number5415334_NexxisOR_P4 | Date17 Oct 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- Barco
- Generic Name
- Operating room audiovisual data/device management system
- Device Name
- MNA-120, MNA-240, MNA-420, MNA-440, NMS 1.18, NMS 2.xx, MNA-420 ENC ANA, MCC-300, MNA-410 WPM
- Model / Ref / Catalog
- Nexxis OR, Nexxis 2.xx, K9351300, MCC-300
- Primary DI / UDI-DI
- 05415334059931
- Basic UDI-DI
- 5415334_NexxisOR_P4
- FDA Product Code
- LMD
- EMDN Code
- Z11069099 Various digital bioimaging management instruments - other
- GMDN Term
- Operating room audiovisual data/device management system
- Device Class
- Class I
- Regulation Number
- 892.2020
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Nexxis OR, Nexxis 2.xx K9351300 | MCC-300 |
Other devices from Barco, Inc.
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No