Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010244786

FEI Number

3010244786

Entity Name

Epsilon Elektronik Sanayi ve Ticaret AS

City/State/Country

Istanbul, TR

Establishment Address

Ferhatpasa Mahallesi 15 Sokak No 126/128, Istanbul 34888, TR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Epsilon Elektronik Sanayi ve Tic A.S (Owner Number: 10086758)

Owner / Operator Contact Address

19 Mayis Mh Dr Sevketbey Sk No 5 Sisli, Istanbul, TR-34 34888, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CBK Series, KSR Series, RKK Series FNT Series DZM Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IXD	Source, Calibration, Sealed, Nuclear	Radiology	Class 1	892.1400	2022-12-13
JAR	Phantom, Test-Pattern, Radionuclide	Radiology	Class 1	892.1420	2022-12-13
IYQ	Phantom, Flood Source, Nuclear	Radiology	Class 1	892.1380	2022-12-13

Official Correspondent

Erdem Ergul

US Agent Details

BARIS KALYONCU Email: bariskalyoncu@gmail.com Phone: (973) 7506315

Related Public Records

Same Entity

Epsilon Elektronik Sanayi ve Tic A.S

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010244786. Last updated year: 2026. Please use registration number 3010244786 when referencing this establishment in official correspondence.