Data / Medical devices / Ireland / Randox Teoranta

Randox Teoranta: FDA-registered device maker in Dungloe Donegal, Ireland, 1 510(k) clearance

Name: Randox Teoranta FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Randox Teoranta is registered with the FDA (registration 3009473156) in Dungloe Donegal, Ireland. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 5, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009473156
Address: Meenmore, Dungloe Donegal, Ireland, F94 TV06
Owner or operator: RANDOX LABORATORIES, LTD. (8020890)
Roles: Foreign private label distributor, Manufacturer
First device listed: March 16, 2004
Registered through: 2026
Brand names listed: ACID WASH SOLUTION (AWS), ACID WASH SOLUTION (WASH SOLN. 3), ALKALINE DETERGENT (Alkaline Detergent), ALKALINE WASH SOLUTION (WASH soln. 9), ANTI-BACTERIAL DETERGENT (Detergent), ASPARTATE AMINOTRANSFERASE (AST), C1 Solution (C1 SOLN), CHLORIDE ISE and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical Use	JJF	1	Foreign private label distributor	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Foreign private label distributor	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Foreign private label distributor	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Foreign private label distributor	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Foreign private label distributor	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Foreign private label distributor	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Foreign private label distributor	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Foreign private label distributor	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 5, 2023	K220451	Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT	DJG	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov

Compare with other makers

Updated October 5, 2023. 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.