Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014928153

FEI Number

3014928153

Entity Name

GENTUG TEKSTIL URUNLERI A.S.

City/State/Country

Istanbul, TR

Establishment Address

Keresteciler Sitesi, Savas Cd, Sogut Sk., No:1, Merter, Istanbul 34010, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gentug Tekstil Urunleri A.S. (Owner Number: 10058588)

Owner / Operator Contact Address

SAVAS CAD. SOGUT SOK. NO:1, GUNGOREN / MERTER, MERTER, TR-34 34010, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Caretex Patient Moving and Handling Textile Products and Draw Sheets Mattress cover (medical purposes)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2018-10-11

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Gentug Tekstil Urunleri 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 3014928153. Last updated year: 2026. Please use registration number 3014928153 when referencing this establishment in official correspondence.