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DORT-A TIP MALZ SAN ITH IHR TIC LTD STI

Türkiye·TR-MF-000019642

Last updated September 17, 2026

About

Reliable Manufacturer Upgrade Sterilization Standards As 4A Medical, we started our activities with the production of sterilization rolls with our own name in 1997. From the day of our foundation, we have created a reliable brand identity in international standards by aiming to continuously improve the critical needs of the health sector. About Us Annual Experience Product Yelpazesi Export to Country

Translated from the manufacturer's own website. Source

What DORT-A TIP MALZ SAN ITH IHR TIC LTD STI makes

The manufacturer produces biliary drainage devices and negative-pressure wound therapy system canisters, including reusable or disposable components for medical use.

These products are classified as Class I, Class IIa, and Class IIb devices and are registered in the EU’s eudamed database. The company is based in Turkey.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does DORT-A TIP MALZ SAN ITH IHR TIC LTD STI manufacture?

DORT-A TIP MALZ SAN ITH IHR TIC LTD STI produces two primary categories of medical devices: biliary drains and negative-pressure wound therapy system canisters. These devices are designed for medical use, including both reusable and disposable components, to support drainage and wound care applications.

Where is DORT-A TIP MALZ SAN ITH IHR TIC LTD STI based?

The company is headquartered in Turkey, as indicated in its regulatory and product documentation. This location is relevant for understanding its operational and compliance context within the EU and other markets.

Which regulatory registries list the devices manufactured by DORT-A TIP MALZ SAN ITH IHR TIC LTD STI?

The devices produced by this manufacturer are listed in the eudamed database, which is the EU’s centralised registry for medical devices. This inclusion ensures transparency and traceability of their products under EU regulatory frameworks.

How are the devices manufactured by DORT-A TIP MALZ SAN ITH IHR TIC LTD STI classified?

The manufacturer’s devices fall into three classification categories: Class I, Class IIa, and Class IIb. Classification determines the regulatory scrutiny and requirements for each device type, with higher classes (e.g., IIb) typically involving stricter safety and performance evaluations due to their associated risks.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Türkiye
Address
Balikhisar mah koyici serpmeleri no:795/A (4A MEDIKAL), Ankara, Türkiye
Phone
+905360343542
PRRC Contact
Gulcin Doner
EUDAMED SRN
TR-MF-000019642
FDA FEI Number
3031982553
DUNS Number
—

Catalogue (268)

Page 2 of 6
DeviceModel / ReferenceRegistriesClassStatus
4a medical 4ATR50100
EUDAMED
Class IActive
4a medical 4ASSD-32
EUDAMED
Class IIaActive
4a medical 4ASMS12001200/60
EUDAMED
Class IActive
4a medical 4AHD600ST14
EUDAMED
Class IIaActive
4a medical 4ASSD-30
EUDAMED
Class IIaActive
4a medical 4AYH-300
EUDAMED
Class IActive
4a medical 4ATR450100
EUDAMED
Class IActive
4a medical 4ATP150200
EUDAMED
Class IActive
4a medical 4ASTRX26
EUDAMED
Class IIaActive
4a medical 4ASMS400400/43
EUDAMED
Class IActive
4a medical 4AHD800DT10
EUDAMED
Class IIaActive
4a medical 4APVCSD-B-27
EUDAMED
Class IIaActive
4a medical 4APVCSD-27
EUDAMED
Class IIaActive
4a medical 4ASMMS500500/60
EUDAMED
Class IActive
4a medical 4ACB2000
EUDAMED
Class IActive
4a medical 4ASMS11001200
EUDAMED
Class IActive
4a medical 4ASSP300390/60/3
EUDAMED
Class IActive
4a medikal 4ACP300300
EUDAMED
Class IActive
4a medical 4AFR500200/70/2
EUDAMED
Class IActive
4a medical 4ASTRX20
EUDAMED
Class IIaActive
4a medical 4AHD600DT18
EUDAMED
Class IIaActive
4a medical 8697442751991
EUDAMED
Class IIaActive
4a medical 4ASSRP
EUDAMED
Class IActive
4a medical 4APVCSD-B-22
EUDAMED
Class IIaActive
4a medical 4APVCSD-18
EUDAMED
Class IIaActive
4a medical 4APVCSD-B-33
EUDAMED
Class IIaActive
4a medical 4ACP900900
EUDAMED
Class IActive
4a medical 4ATP200250
EUDAMED
Class IActive
4a medical 4AHD600ST16
EUDAMED
Class IIaActive
4a medical 4APVC-BR250
EUDAMED
Class IIaActive
4a medical 4ARFP
EUDAMED
Class IActive
4a medical 4ASSP300400/60/3
EUDAMED
Class IActive
4a medical 4AYSW-V-180
EUDAMED
Class IIaActive
4a medical 4AYSW-OUTV-200
EUDAMED
Class IIaActive
4a medikal 4ANPR400200
EUDAMED
Class IActive
4a medical 4ASSD-15
EUDAMED
Class IIaActive
4a medical 4ASMS900900/43
EUDAMED
Class IActive
4a medical 4ASMS300300/60
EUDAMED
Class IActive
4a medical 4APVCSD-B-24
EUDAMED
Class IIaActive
4a medical 4AHDPVC-BR125-ST10
EUDAMED
Class IIaActive
4a medical 4ASSD-B-24
EUDAMED
Class IIaActive
4a medikal 4ANPR300200
EUDAMED
Class IActive
4a medical 4AHD600DT10
EUDAMED
Class IIaActive
4a medical 4ASTD18
EUDAMED
Class IIaActive
4a medical 4ASTD16
EUDAMED
Class IIaActive
4a medical 4APD12
EUDAMED
Class IIaActive
4a medical 4ATP
EUDAMED
Class IActive
4a medical 4ATR120100
EUDAMED
Class IActive
4a medical 4AFR5002000/70/2
EUDAMED
Class IActive
4a medical 4ARFR100100/60/3
EUDAMED
Class IActive

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