Skip to the page

Data / Medical devices / Electrode, Ion Specific, Sodium

Electrode, Ion Specific, Sodium (JGS): 72 FDA-registered makers in 15 countries

72 establishments in 15 countries are registered with the FDA to make Electrode, Ion Specific, Sodium (product code JGS, Class 2, 21 CFR 862.1665). 33 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 162 510(k) clearances under this code, the latest on May 1, 2026, and lists 34 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
JGS
Device class
2
Regulation
862.1665
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States34
Japan8
Germany6
Canada4
China3
United Kingdom3
Ireland2
France2
Italy2
Switzerland2
Poland2
Hungary1
Denmark1
Netherlands1
Mexico1

Makers of Electrode, Ion Specific, Sodium

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, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer9July 19, 2019010api.fda.gov
Abbott Point Of Care Canada LimitedOttawa Ontario, CanadaManufacturer6October 27, 2023000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer5February 2, 2001000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer4August 22, 2012000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer4July 19, 2019000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer4July 25, 20230150api.fda.gov
Abbott Point Of Care Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer3October 27, 2023040api.fda.gov
Diamond Diagnostics Inc.Budapest, HungaryContract manufacturer, Exporter to the US3December 16, 2016000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2December 27, 2004000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer2July 25, 2023000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer2March 9, 2017000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer1October 25, 1999000api.fda.gov
Awareness Technology, Inc.Palm City, FL, United StatesManufacturer1February 27, 2018000api.fda.gov
Abbott Automation Solutions GmbHHamburg, GermanyManufacturer1March 10, 2022000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer, Manufacturer1July 21, 1992000api.fda.gov
Beckman Coulter K. K.Sunto-Gun Shizuoka, JapanSpecification developer1December 16, 2016000api.fda.gov
Epocal, Inc.Ottawa Ontario, CanadaManufacturer, Specification developer1September 27, 2006000api.fda.gov
Epocal IncOttawa Ontario, CanadaManufacturer, Specification developer1September 27, 2006000api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer1February 16, 2019000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Repackager or relabeler1December 14, 2016000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1June 20, 1995000api.fda.gov
Jeol Ltd.Musashimurayama Tokyo, JapanManufacturer1May 21, 1999000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1June 30, 2008020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1June 30, 2008020api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer1December 22, 2004000api.fda.gov
Radiometer Medical ApsBROENSHOEJ Hovedstaden, DenmarkComplaint file establishment, Manufacturer1May 1, 2026000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer1October 24, 1996000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler1April 6, 2010000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1June 9, 2016000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing LtdSUDBURY Suffolk, United KingdomManufacturer, Specification developer1May 28, 1987000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer1June 9, 2016000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer1March 24, 2011000api.fda.gov
VitalScientific B.V.SPANKEREN Gelderland, NetherlandsContract manufacturer, Manufacturer1March 24, 2011000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Abbott Laboratories de MexicoCuautitlan Izcalli Mexico, MexicoContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer0030api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer0000api.fda.gov
BIOTECNICA INSTRUMENTS, SrlROME Roma, ItalyManufacturer0000api.fda.gov
Beckman Coulter Mishima K.K.SUNTO-GUN Shizuoka, JapanContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Hebron, KY, United StatesContract manufacturer0000api.fda.gov
Biolis Medical Corp.Hino Tokyo, JapanManufacturer0000api.fda.gov
Canon Inc.OTAWARA-SHI Tochigi, JapanContract manufacturer0000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer0000api.fda.gov
Currier PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
Ever Pharma JenaJena Thuringia, GermanyContract manufacturer0000api.fda.gov
Furuno Electric Co., Ltd.NISHINOMIYA-CITY Hyogo, JapanManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Hitachi High-Tech Corp., Naka DivisionHitachinaka-shi Ibaraki, JapanContract manufacturer0000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceManufacturer, Specification developer0000api.fda.gov
Horiba Ltd.Kyoto, JapanContract manufacturer, Exporter to the US, Specification developer0000api.fda.gov
Inpeco S.P.A.Val della Torre Torino, ItalyContract manufacturer0000api.fda.gov
Inpeco SANovazzano Ticino, SwitzerlandSpecification developer0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer0010api.fda.gov
Phoenix Diagnostics, Inc.Natick, MA, United StatesManufacturer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer, Repackager or relabeler0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer, Specification developer0000api.fda.gov
Radiometer MinneapolisNew Brighton, MN, United StatesManufacturer0000api.fda.gov
Radiometer Solutions Sp. z o.o.Stargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Radiometer Sp. z o.oStargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Sanzay Corporation -Miami Gardens, FL, United StatesRemanufacturer0000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaContract manufacturer0000api.fda.gov
Siegfried Hameln GmbHHameln Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov

Updated May 1, 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.