Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024379638

FEI Number

3024379638

Entity Name

IPEK IDROFIL PAMUK SAN. VE TIC. A.S.

City/State/Country

ISTANBUL, TR

Establishment Address

Barbaros Mah. Ardic Sok. Varyap Meridian Sitesi No: 4, G-1 Blok D:17-18-19-20 Atasehir, ISTANBUL 34647, TR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IPEK IDROFIL PAMUK SAN. VE TIC. A.S. (Owner Number: 10089388)

Owner / Operator Contact Address

Barbaros Mah. Ardic Sok. Varyap Meridian Sitesi No: 4, G-1 Blok D:17-18-19-20 Atasehir, ISTANBUL, TR-34 34647, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-12-04

Official Correspondent

Tugba Oklu

US Agent Details

Clay Fesperman Business: American Fiber & Finishing Inc. Email: clay.fesperman@affinc.com Phone: (704) 9849217

Related Public Records

Same Entity

IPEK IDROFIL PAMUK SAN. VE TIC. A.S.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3004651943	KURTSAN PHARMACEUTICALS, INC.	Bandirma Balikesir, TR
3012047128	ATHFAR 828, Inc.	Big Rapids, MI, US
3014666579	SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Zaozhuang Shandong, CN
3007663056	SHANGHAI HUIHU MEDICAL APPLIANCE CO. LTD.	Shanghai, CN
3015068387	GEORGE COUREY INC	Montreal Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024379638. Last updated year: 2026. Please use registration number 3024379638 when referencing this establishment in official correspondence.