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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

CountryMakers
United States17
Canada3
Poland2
United Kingdom1
Denmark1
China1
Switzerland1
Italy1
France1
Netherlands1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer16July 17, 2018040api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer9July 17, 2018000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer8March 27, 2020020api.fda.gov
Siemens Healthcare Diagnostics Manufacturing LtdSUDBURY Suffolk, United KingdomManufacturer, Specification developer7March 27, 2020000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer7March 27, 20200150api.fda.gov
Abbott Point Of Care Canada LimitedOttawa Ontario, CanadaManufacturer5May 2, 2025000api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer5August 10, 2023070api.fda.gov
Radiometer Medical ApsBROENSHOEJ Hovedstaden, DenmarkComplaint file establishment, Manufacturer5April 10, 20260120api.fda.gov
Abbott Point Of Care Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer4May 2, 20250140api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Repackager or relabeler4August 10, 2023000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer3June 25, 2007000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer2August 22, 2013010api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer2December 17, 2003010api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer, Manufacturer1January 3, 1994000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer1July 15, 2016000api.fda.gov
Epocal, Inc.Ottawa Ontario, CanadaManufacturer, Specification developer1June 5, 2020000api.fda.gov
Epocal IncOttawa Ontario, CanadaManufacturer, Specification developer1June 5, 2020000api.fda.gov
Phoenix Diagnostics, Inc.Natick, MA, United StatesManufacturer1June 12, 1990000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer1May 14, 2012000api.fda.gov
Radiometer MinneapolisNew Brighton, MN, United StatesManufacturer, Manufacturer for export1August 6, 2015000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer0000api.fda.gov
BIOTECNICA INSTRUMENTS, SrlROME Roma, ItalyManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Radiometer Solutions Sp. z o.o.Stargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Radiometer Sp. z o.oStargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer0000api.fda.gov
VitalScientific B.V.SPANKEREN Gelderland, NetherlandsContract manufacturer0000api.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.