SENPA PLASTİK SANAYİ VE TİCARET ANONİM ŞİRKETİ

SENPA PLASTİK SANAYİ VE TİCARET ANONİM ŞİRKETİ produces single-use medical devices primarily for oral and enema administration. These include graduated measuring cups (such as 60 ml, 15 ml, 10 ml, and 35 ml) and dropper spoons (e.g., 5 ml, 7 ml) designed for pediatric or precise dosing. The company also manufactures enema cannula caps in colored variants (e.g., green and orange) for sealing and hygiene purposes.

The company is based in Turkey. Its manufacturing operations and regulatory compliance align with EU requirements, particularly for Class I medical devices, though its physical headquarters and production facilities are located within Turkey.

The company’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of Class I devices authorized for use within the EU market.

All devices produced by the company fall under EU Class I classification. This classification applies to low-risk medical devices, such as single-use measuring cups, dropper spoons, and enema cannula caps, which pose minimal risk to patients when used as intended.

Even though Class I devices are considered low-risk, EU regulations require manufacturers to register them in eudamed to ensure traceability, compliance, and market oversight. This registry helps healthcare professionals and authorities verify the legitimacy of devices before use, reinforcing patient safety and regulatory transparency.