Exalenz Bioscience, Ltd.
Country not established
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Exalenz Bioscience, Ltd. makes
Exalenz Bioscience, Ltd. manufactures handheld and laboratory breath analysis systems designed to detect volatile organic compounds (VOCs) for medical screening, including the BreathID Smart System and BreathID HP System variants. These devices are intended for non-invasive diagnostic applications, such as identifying metabolic disorders or infectious diseases through exhaled breath analysis.
The company’s breath analysis systems are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records. These products are listed in the FDA’s regulatory database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
BreathID Smart System Ref K193610
510(k) 510(k)Breathid Hp System Ref K130524
510(k) 510(k)BreathID Hp Lab System Ref K162150
510(k) 510(k)BreathID Hp System Ref K173772
510(k) 510(k)BreathID Hp Lab System Ref K173777
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Exalenz Bioscience, Ltd., initiated on 2011-06-07. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 7 Jun 2011 Z-0042-2012 Unclassified (pre-2012) Terminated The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted).
Frequently asked questions
How many devices does Exalenz Bioscience, Ltd. have in the registry?
The registry currently lists 5 devices for Exalenz Bioscience, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Exalenz Bioscience, Ltd.'s devices?
Among its 5 most recently registered devices, Exalenz Bioscience, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Exalenz Bioscience, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Exalenz Bioscience, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Exalenz Bioscience, Ltd.?
FDA recall records list 1 recall initiated by Exalenz Bioscience, Ltd., the most recent initiated on 2011-06-07. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Exalenz Bioscience, Ltd. in the registry?
The most recently registered devices listed for Exalenz Bioscience, Ltd. include BreathID Smart System, BREATHID HP SYSTEM and BreathID Hp Lab System.