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Nio Color 2MP LED

FDA UDI

Class II (US FDA UDI)

by Barco, Inc.

Identity

Trade Name
Nio Color 2MP LED FDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Device Name
MDNC-2221 NC MKIII FDA UDI
Model / Reference
MDNC-2221 FDA UDI
Description
MDNC-2221 NC MKIII FDA UDI

Identifiers

Catalog Number
K9301649C FDA UDI
Primary DI / UDI-DI
05415334031593 FDA UDI
510(k) Number
K133663 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Radiology picture archiving and communication system workstation

Nio Color 2MP LED by Barco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system workstation.

Cleared under the same submission

K133663 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Barco, Inc.

Sources (1)

  • FDA UDI d01ea8ce-a49e-455c-aacb-8b19f58a03b7 36 fields · synced May 30, 2026