NIOX ARTICLE NO: 02-1000

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NObreath®

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fenom Pro Nitric Oxide Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NIOX VERO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fenom Pro

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Vivatmo pro

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NIOX VERO Airway Inflammation Monitor

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

APIERON INSIGHT ENO SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NIOX VERO AIRWAY INFLAMMATION MONITOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NIOX MINO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CRP/MxA Combo Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device

LUCIA™ MxA for whole blood samples

Basic UDI-DI

EU IVDD · Eu Ivd General ·Labmaster Oy·1 device

System, Test, Breath Nitric Oxide

FDA classification

FDA Class 2 ·System, Test, Breath Nitric Oxide

Neitz Halogen Ophthalmoscope BXa-13

FDA registration

NEITZ INSTRUMENTS COMPANY, LTD.·1 product·🇯🇵 Japan

Halogen Ophthalmoscope BXa-RC

FDA registration

NEITZ INSTRUMENTS COMPANY, LTD.·1 product·🇯🇵 Japan

Measurement Specialties Inc.

Manufacturer

🇺🇸 United States·37 Basic UDI-DIs·37 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

max mjj

Manufacturer

🇫🇷 France

DxA 5000 Fit

FDA registration

Beckman Coulter Biomedical GmbH·1 product·🇩🇪 Germany