Pergo Medikal ve Ilac Sanayi A.S.

Pergo Medikal ve Ilac Sanayi A.S. produces a range of medical devices primarily focused on airway management and surgical applications. Their portfolio includes endotracheal tubes (such as LOREMED, Pennamed, and VYTIL), suction liner extension tubes (e.g., sterile 210 cm tubes with bubble connectors and rubber bands), and keyhole surgical instruments (e.g., Key Surgical). These devices are designed for use in respiratory and surgical procedures, covering both reusable and single-use options.

Pergo Medikal ve Ilac Sanayi A.S. is headquartered in Turkey. The company’s location influences its regulatory compliance requirements, particularly for devices marketed in the EU or other regions with jurisdiction over Turkish manufacturers.

Pergo Medikal ve Ilac Sanayi A.S.’s devices are listed in the eudamed database, which is the EU’s centralised registry for medical devices. This registry is used to track manufacturers, devices, and their regulatory status under EU Medical Device Regulations (MDR). Listing in eudamed ensures transparency and compliance with EU requirements for devices classified as Class I or Class IIa.

Pergo Medikal ve Ilac Sanayi A.S.’s devices fall under Class I and Class IIa classifications in the EU Medical Device Regulations. Classification determines the regulatory pathway and risk-based requirements for market placement. For example, Class I devices generally pose lower risks and may require less stringent documentation, while Class IIa devices involve moderate risks and require additional conformity assessments, such as clinical evaluations or designated conformity assessment bodies.