Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031982553

FEI Number

3031982553

Entity Name

DORT-A TIP MALZ SAN ITH IHR TIC LTD STI

City/State/Country

ANKARA, TR

Establishment Address

Balikhisar Mah Koyici Serpmeleri No:795/A Akyurt, ANKARA 06750, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DORT-A TIP MALZ SAN ITH IHR TIC LTD STI (Owner Number: 10091243)

Owner / Operator Contact Address

Balikhisar Mah Koyici Serpmeleri No:795/A Akyurt, ANKARA, TR-06 06750, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240910

PMA Number

N/A

All Registered Proprietary Names

EO Chex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-07-31

Official Correspondent

Gulcin Doner

US Agent Details

Andrew Sharavara Email: as@proppermfg.com Phone: (718) 3926650

Related Public Records

Same Entity

DORT-A TIP MALZ SAN ITH IHR TIC LTD STI

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-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

Similar Registrations

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3007412809	STERIS Corporation	FRANKLIN PARK, IL, US
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3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031982553. Last updated year: 2026. Please use registration number 3031982553 when referencing this establishment in official correspondence.