System, Breath Measurement

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Hong Kong and Zhejiang: 3 hold an FDA registration.

QI Diagnostics Limited Hong Kong
Rayco Electronic Ltd. Guangdong
Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer

What Is This Device?

Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.

How Is NRH Classified?

System, Breath Measurement is FDA product code NRH, Class 1, 21 CFR 862.1820.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2025. None was by a company in China. The root cause the FDA records most often is No Marketing Application (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

System, Breath Measurement

Vial Adapter, Plastic, 5 Pack

Catalogue number QT02688, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Drying Tube End, Sample Inlet, Female

Catalogue number QT01134, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Drying Tube End, Sample Inlet, Male

Catalogue number QT01135, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Breathtracker Series Repair

Catalogue number QTMBT, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

BreathTracker

BreathTracker Model H2 Plus (100-120V)

System, Breath Measurement

Screwdriver, Valve Removal Tool

Catalogue number QT02643, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Pure Comfort Breath Exerciser

Catalogue number 7830, listed by Home Aide Diagnostics, Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

BreathPrep Desiccant

Component of the BreathTracker medical device.

System, Breath Measurement

SX2 Plus Maintenance Kit

KIT, SX2 Plus Maintenance

System, Breath Measurement

Extractor Repair

Catalogue number QTMSX, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Dust Barrier, 5 Pack

Catalogue number QT01140-K, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Loaner Alveovac Extractor

Catalogue number QTLNRAV, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Filter, Foam Plug, 10 Pack

Catalogue number QT00527-T, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

BT GC Loaner SC

Catalogue number QTLNRBTGCSC, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Stopcock, ONE-WAY, Plastic

Catalogue number QT01727-V, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

SivRite-4 Tubing Assembly

Catalogue number QT02509, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Gastrolyzer

The GastroGENIUS® is a portable desktop monitor which measures hydrogen (H2), methane (CH4) and oxygen (O2) leaves in expired breath samples in response to appropriate substrates. It is…

System, Breath Measurement

BT Upgrade, CUI, Inc Power Supplies

Catalogue number QT06011-UP, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Extraction System Output Tubing

Catalogue number QT02704, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

AlveoVac Exraction System-USA 24VDC

A stand-alone accessory which extracts breath samples from approved QuinTron breath collection devices and injects the sample into the BreathTracker SC or H2+ breath analyzer. Approved…

System, Breath Measurement

Patient Sample Drying Tube

Drying Tube, Patient Sample

System, Breath Measurement

Sugar, Rx, Lactulose, 10 GM Syrup, USP

Catalogue number QT02770, listed by Quintron Instrument Co., Inc., United States, under System, Breath Measurement. 3 manufacturers in China are registered for this product code.

System, Breath Measurement

Tank Support, Safety, Table-Top Plastic

Tank Support, Safety, Table-TOP, Plastic

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer