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Niox

FDA UDI

Class II (US FDA UDI)

by Circassia AB

Identity

Trade Name
NIOX FDA UDI
Generic Name
Nitrogen monoxide analyser FDA UDI
Device Name
The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50，100，300，500 or 1000 tests. FDA UDI
Model / Reference
MINO Sensor 50 FDA UDI
Description
The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50，100，300，500 or 1000 tests. FDA UDI

Identifiers

Catalog Number
03-2005 FDA UDI
Primary DI / UDI-DI
07350047030052 FDA UDI
510(k) Number
K101034 FDA UDI
FDA Product Code
MXA FDA UDI
GMDN Term
Nitrogen monoxide analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3080 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nitrogen monoxide analyser

Niox by Circassia AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrogen monoxide analyser.

Cleared under the same submission

K101034 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Circassia AB

Sources (1)

  • FDA UDI ea7098e3-eaf9-4ca1-a4d1-2e55b112f90d 37 fields · synced Jun 1, 2026