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MEDICON HELLAS SA

Greece · Gerakas Attiki

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

21listed device types

Class I 12Class II 9Class III 0

plus 13 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States13 registration records, 3 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 2 excluded

Manufacturer names merged into this page: MEDICON HELLAS SA

FDA 510(k) clearances by year

12006 · K062746

12021 · K200898

12024 · K232404

FDA listed device types

showing 8 of 21

Antisera, All Groups, Streptococcus Spp. 1Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1Nadh Oxidation/Nad Reduction, Alt/Sgpt 1Acid, Uric, Uricase (Colorimetric) 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Ferrozine (Colorimetric) Iron Binding Capacity 1System, Test, Low Density, Lipoprotein 1Enzymatic Esterase--Oxidase, Cholesterol 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232404	CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES	2024-08-09
US	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	2021-09-21
US	K062746	FERRITIN-LATEX, MODELS 1418-2070, 1418-0279	2006-11-20

MEDICON HELLAS SA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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