Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018077255

FEI Number

3018077255

Entity Name

KONFORT OZEL SAGLIK HIZMETLERI TIBBI MALZ. SAN VE TIC LTD STI

City/State/Country

ESKISEHIR, TR

Establishment Address

ORGANIZE SANAYI BOLGESI 9. CADDE NO:32 ODUNPAZARI, ESKISEHIR 26250, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KONFORT OZEL SAGLIK HIZMETLERI TIBBI MALZ. SAN VE TIC LTD ST (Owner Number: 10080002)

Owner / Operator Contact Address

ORGANIZE SANAYI BOLGESI 9. CADDE NO:32 ODUNPAZARI, ESKISEHIR, TR-26 26110, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Two Pieces Colostomy&Ileostomy Bag Closed 57mm With Filter Opaque One Piece Colostomy&Ileostomy Bag Drainable Post-op 100mm Transparent Standard Flange 12-45mm One Piece Drainable Pediatric Bag With Filter 12- 45mm Two Pieces Colostomy&Ileostomy Bag Drainable 57mm With Filter Transparent Two Pieces Colostomy&Ileostomy Bag Closed 45mm With Filter Opaque Two Pieces Colostomy&Ileostomy Bag Drainable 57mm With Filter Opaque Standard Flange 12-57mm Ostomy Paste Two Pieces Urostomy Bag Drainable 45mm Two Pieces Colostomy&Ileostomy Bag Drainable 70mm With Filter Opaque Flange with Barrier 12-70mm Two Pieces Colostomy&Ileostomy Bag Closed 70mm With Filter Transparent Ostomy Powder Two Pieces Colostomy&Ileostomy Bag Drainable 45mm With Filter Transparent Skin Barrier Cream One Piece Urostomy Bag Drainable 12-70mm One Piece Colostomy & Ileostomy Bag Drainable 12-70mm With Filter Opaque Flange with Barrier 12-57mm Two Pieces Urostomy Bag Drainable 70mm Standard Flange 12-70mm One Piece Drainable Pediatric Bag 12- 40mm One Piece Colostomy&Ileostomy Bag Closed 12-70mm With Filter Opaque Two Pieces Colostomy&Ileostomy Bag Closed 45mm With Filter Transparent One Piece Colostomy&Ileostomy Bag Drainable 12-70mm With Filter Transparent Adhesive Remover Flange with Barrier 12-45mm Two Pieces Urostomy Bag Drainable 57mm Two Pieces Colostomy&Ileostomy Bag Drainable 45mm With Filter Opaque Two Pieces Colostomy&Ileostomy Bag Closed 70mm With Filter Opaque Ostomy Belt One Piece Colostomy&Ileostomy Bag Closed 12-70mm With Filter Transparent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2021-02-10

Official Correspondent

SECIL ERGUN

US Agent Details

ALI ERTUG CINAR Email: cinaraliertug@gmail.com Phone: (973) 9807376

Related Public Records

Same Entity

KONFORT OZEL SAGLIK HIZMETLERI TIBBI MALZ. SAN VE TIC LTD ST

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

Similar Registrations

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3011707784	CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.	Changshu Jiangsu, CN
3008244559	CASEX, LTDA	Curitiba Parana, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018077255. Last updated year: 2026. Please use registration number 3018077255 when referencing this establishment in official correspondence.