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Data / Medical devices / Calibrator, Secondary / Ireland

FDA-registered makers of Calibrator, Secondary in Ireland: 6 establishments

6 establishments in Ireland are registered with the FDA to make Calibrator, Secondary (product code JIT). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Calibrator, Secondary
Product code
JIT
Country
Ireland

Makers of Calibrator, Secondary in Ireland

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer4February 15, 2017000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer, Manufacturer4June 30, 2014000api.fda.gov
Trinity Biotech, PlcBRAY Wicklow, IrelandManufacturer1August 21, 1987000api.fda.gov
Abbott IrelandSligo, IrelandManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov
Waters Technologies Ireland, Ltd.DRINAGH Wexford, IrelandSpecification developer0000api.fda.gov

Updated November 2, 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.