Exalenz BreathID Hp Breath Test System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Class:

Class B medical device

Manufactured by:

Exalenz Bioscience Ltd.

Therapeutic area:

Gastroenterology & Urology

Therapeutic indications:

The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. The device is for use by trained health care professionals. To be administered under a physician’s supervision.

Product summary:

Models: BreathID Hp - VS01000

Authorization date:

2016-04-29