Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008662397

FEI Number

3008662397

Entity Name

NIOX AB

City/State/Country

Uppsala, SE

Establishment Address

Hansellisgatan 13, Uppsala SE 754 50, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Circassia Inc (Owner Number: 9057041)

Owner / Operator Contact Address

1100 Perimeter Park Dr., STE 114, Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150233

PMA Number

N/A

All Registered Proprietary Names

NIOX NIOX NIOX NIOX NIOX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2018-04-20
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2008-02-28
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2013-12-18
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2010-12-17
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2015-03-25

Official Correspondent

Tom Scaccia

US Agent Details

Tom Scaccia Business: NIOX Inc Email: tom.scaccia@niox.com Phone: (866) 2756469

Related Public Records

Same Entity

Circassia Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012926714	NIOX Group Plc	Oxford Oxfordshire, GB

Similar Registrations

Registration Number	Establishment Name	Location
3001082393	BOSCH HEALTHCARE SOLUTIONS GMBH	Waiblingen Baden-Wurttemberg, DE
3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE
3004167884	PHC Corporation	MIMA Tokushima, JP
3012926714	NIOX Group Plc	Oxford Oxfordshire, GB
3010381606	EMSERE BV	Leiden Zuid-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008662397. Last updated year: 2026. Please use registration number 3008662397 when referencing this establishment in official correspondence.