Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006716639

FEI Number

3006716639

Entity Name

MEDICON HELLAS SA

City/State/Country

GERAKAS Attiki, GR

Establishment Address

MELITONA 5-7, GERAKAS Attiki 15344, GR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDICON HELLAS SA (Owner Number: 10036719)

Owner / Operator Contact Address

MELITONA 5-7, GERAKAS, GR-I 15344, GR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Iron ALT/SPGT LDH GGT Uric Acid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2023-10-09
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2023-10-09
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2023-10-09
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2023-10-09
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2023-10-09

Official Correspondent

SOTIRIA MITROPOULOU

US Agent Details

Frank Matuszak Business: Diatron US Inc. Email: Frank.Matuszak@Diatron.com Phone: (833) 2287931

Related Public Records

Same Entity

MEDICON HELLAS SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K842244	Diagnostic Chemicals, Ltd. (Usa)	LACTATE DENYDRO GENASE ASSAY KIT	1984-07-18
K830679	Dow Instruments & Reagents, Inc.	URIC ACID COLORIMETRIC DETERMINATION	1983-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2009	Roche Diagnostics Corp.	1	Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of iron in serum and plasma.

Similar Registrations

Registration Number	Establishment Name	Location
2517506	SIEMENS HEALTHCARE DIAGNOSTICS INC.	NEWARK, DE, US
3005094123	ABBOTT IRELAND DIAGNOSTICS DIVISION	Longford, IE
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006716639. Last updated year: 2026. Please use registration number 3006716639 when referencing this establishment in official correspondence.