Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012290852

FEI Number

3012290852

Entity Name

Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti

City/State/Country

Bakirkoy Istanbul, TR

Establishment Address

Yesilkoy SB Mah, E Blok Sok, Occlutech Apt. No:6, Bakirkoy Istanbul 34149, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Occlutech Holding AG (Owner Number: 10084004)

Owner / Operator Contact Address

Feldstrasse 22, Schaffhausen, CH-SH 8200, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P200032

All Registered Proprietary Names

Occlutech ASD Occluder and 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	2024-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

Christine Lee Business: OCCLUTECH US LLC Email: christine.lee@occlutech.com Phone: (404) 4227739

Related Public Records

Same Entity

Occlutech Holding AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014616394	Occlutech GmbH	Jena Thuringia, DE
3012613541	Occlutech International AB	Helsingborg Skane, SE

Similar Registrations

Registration Number	Establishment Name	Location
3017907716	SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI	esenyurt 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 3012290852. Last updated year: 2026. Please use registration number 3012290852 when referencing this establishment in official correspondence.