DORT-A TIP MALZ SAN ITH IHR TIC LTD STI

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.

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.

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.

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.