Data / Medical devices / System, Breath Measurement
System, Breath Measurement (NRH): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make System, Breath Measurement (product code NRH, Class 1, 21 CFR 862.1820). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on May 19, 2004, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NRH
- Device class
- 1
- Regulation
- 862.1820
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United Kingdom | 3 |
| China | 3 |
| South Korea | 2 |
| Brazil | 1 |
| Ireland | 1 |
| United States | 1 |
Makers of System, Breath Measurement
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alacer Industria Eletronica Ltda | Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bedfont Scientific Ltd. | MAIDSTONE Kent, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FoodMarble Digestive Health Limited | Dublin 8 Dublin(County), Ireland | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huwant Corp. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MD Diagnostics Ltd | Chatham Kent, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Owlstone Medical Ltd | Cambridge Cambridgeshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qi Diagnostics Limited | Mongkok Hong Kong, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quintron Instrument Co. Inc. | New Berlin, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayco Electronic Ltd. | Dong Guan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SENTECH GMI Corp | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 19, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.