Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613847

FEI Number

3002807672

Entity Name

MAK-SYSTEM Group Ltd.

City/State/Country

London London, City of, GB

Establishment Address

C/O Csc Cls (Uk) Limited 5 Churchill Place, 10th Floor, London London, City of E14 5HU, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAK-SYSTEM Group Ltd. (Owner Number: 9025329)

Owner / Operator Contact Address

C/O Csc Cls (Uk) Limited 5 Churchill Place, 10th Floor, London, GB-LND E14 5HU, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK080002

PMA Number

N/A

All Registered Proprietary Names

eProgesa

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2013-07-16

Official Correspondent

FRANK JAUBERT

US Agent Details

Frank Jaubert Business: MAK-SYSTEM Corp Email: regulatory@mak-system.net Phone: (919) 5057839

Related Public Records

Same Entity

MAK-SYSTEM Group Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1423641	MAK-SYSTEM CORP.	DES PLAINES, IL, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613847. Last updated year: 2026. Please use registration number 9613847 when referencing this establishment in official correspondence.