MAK-SYSTEM CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1423641	3000215342	MAK-SYSTEM CORP.	1	Y	2026-01-01	2720 RIVER RD., SUITE 225 DES PLAINES IL US 60018
9613847	3002807672	MAK-SYSTEM Group Ltd.	1	N	2026-01-01	C/O Csc Cls (Uk) Limited 5 Churchill Place, 10th Floor London London, City of GB E14 5HU

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission
52124	1967262865	BK251188
52124	1627223623	BK230986
52124	1300617604	BK180232
16378	1674083945	BK080002
52124	1674083945	BK080002
16378	1061948824	BK070062
52124	1061948824	BK070062
16378	2028326998	BK060035
52124	2028326998	BK060035

PMN#

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2018-10-18

MAK-SYSTEM SA International Group

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2008-05-13

MAK-System

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2007-10-26

MAK-System

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2007-05-09

MAK-System

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

1998-12-10

MAK-System

GUDID#

Patient Health Software (P.H.S) - v11.0.0.0

MAK-SYSTEM GROUP LIMITED

2025-12-15

ePROGESA - v5.0.3

MAK-SYSTEM GROUP LIMITED

2024-11-27

Patient Health Software (P.H.S) - v2.0

MAK-SYSTEM GROUP LIMITED

2023-07-12

ePROGESA - 5.0.1

MAK-SYSTEM GROUP LIMITED

2023-06-29