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Medicon Hellas SA: FDA-registered device maker in GERAKAS Attiki, Greece, 2 510(k) clearances

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

Medicon Hellas SA is registered with the FDA (registration 3006716639) in GERAKAS Attiki, Greece. It lists 21 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 9, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006716639
Address: Melitona 5-7, GERAKAS Attiki, Greece, 15344
Owner or operator: MEDICON HELLAS SA (10036719)
Roles: Contract manufacturer, Manufacturer
First device listed: May 23, 2011
Registered through: 2026
Brand names listed: ALT/SPGT, ASO, AST/SGOT, CHOLESTEROL, GGT, HDL-Cholesterol, Iron, LDH and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Uric, Uricase (Colorimetric)	KNK	1	Manufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.	GTZ	1	Manufacturer	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
Colorimetric Method, Gamma-Glutamyl Transpeptidase	JPZ	1	Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Manufacturer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	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
August 9, 2024	K232404	CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES	CHH	Substantially Equivalent	Medicon Hellas S.A	accessdata.fda.gov
September 21, 2021	K200898	Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin	CIX	Substantially Equivalent	Medicon Hellas S.A	accessdata.fda.gov

Compare with other makers

Updated August 9, 2024. 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.