Data / Medical devices / Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (CHL): 29 FDA-registered makers in 10 countries
29 establishments in 10 countries are registered with the FDA to make Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (product code CHL, Class 2, 21 CFR 862.1120). 20 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 188 510(k) clearances under this code, the latest on April 10, 2026, and lists 93 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CHL
- Device class
- 2
- Regulation
- 862.1120
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 17 |
| Canada | 3 |
| Poland | 2 |
| United Kingdom | 1 |
| Denmark | 1 |
| China | 1 |
| Switzerland | 1 |
| Italy | 1 |
| France | 1 |
| Netherlands | 1 |
Makers of Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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 |
|---|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer | 16 | July 17, 2018 | 0 | 4 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 9 | July 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 8 | March 27, 2020 | 0 | 2 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Manufacturing Ltd | SUDBURY Suffolk, United Kingdom | Manufacturer, Specification developer | 7 | March 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 7 | March 27, 2020 | 0 | 15 | 0 | api.fda.gov |
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Manufacturer | 5 | May 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 5 | August 10, 2023 | 0 | 7 | 0 | api.fda.gov |
| Radiometer Medical Aps | BROENSHOEJ Hovedstaden, Denmark | Complaint file establishment, Manufacturer | 5 | April 10, 2026 | 0 | 12 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | May 2, 2025 | 0 | 14 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Repackager or relabeler | 4 | August 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 3 | June 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| Opti Medical Systems Inc. | Roswell, GA, United States | Manufacturer | 2 | August 22, 2013 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | December 17, 2003 | 0 | 1 | 0 | api.fda.gov |
| Bionostics, Inc. | Devens, MA, United States | Contract manufacturer, Manufacturer | 1 | January 3, 1994 | 0 | 0 | 0 | api.fda.gov |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 1 | July 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Epocal, Inc. | Ottawa Ontario, Canada | Manufacturer, Specification developer | 1 | June 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Epocal Inc | Ottawa Ontario, Canada | Manufacturer, Specification developer | 1 | June 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Phoenix Diagnostics, Inc. | Natick, MA, United States | Manufacturer | 1 | June 12, 1990 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 1 | May 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Radiometer Minneapolis | New Brighton, MN, United States | Manufacturer, Manufacturer for export | 1 | August 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BIOTECNICA INSTRUMENTS, Srl | ROME Roma, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Solutions Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Sp. z o.o | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| VitalScientific | SEES Normandie, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VitalScientific B.V. | SPANKEREN Gelderland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 10, 2026. 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.