Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017907716

FEI Number

3017907716

Entity Name

SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI

City/State/Country

esenyurt Istanbul, TR

Establishment Address

Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt, esenyurt Istanbul 34522, TR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Set Medikal Sanayi Ve Ticaret Anonim Sirketi (Owner Number: 10079852)

Owner / Operator Contact Address

Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt, Istanbul, TR-34 34522, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Occlutech® ASD Occluder Occlutech® Pistol Pusher

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZG	Transcatheter Septal Occluder (Atrial)	Unknown	Class 3	N/A	2024-02-21

Official Correspondent

Egemen Serbetci

US Agent Details

Murat Acar Business: One Life Sciences Email: onelifesciencesllc@gmail.com Phone: (702) 5768082

Related Public Records

Same Entity

Set Medikal Sanayi Ve Ticaret Anonim Sirketi

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3012290852	Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti	Bakirkoy Istanbul, TR
3014616394	Occlutech GmbH	Jena Thuringia, DE
9617429	MEDICOPLAST INTERNATIONAL GMBH	ILLINGEN Saarland, DE
3012613541	Occlutech International AB	Helsingborg Skane, SE
3031365458	WOMED SAS	Montpellier Herault, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017907716. Last updated year: 2026. Please use registration number 3017907716 when referencing this establishment in official correspondence.