Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.

Plasti-med produces a range of medical devices, including single-use and reusable products. Their most common offerings are negative-pressure wound therapy system canisters, manual pulmonary resuscitators, non-bioabsorbable closed-wound drains, suction/irrigation tubing, sterilization/disinfection containers, anaesthesia face masks, and secretion suction kits. These devices serve critical roles in wound care, resuscitation, drainage, and anaesthesia.

Plasti-med is based in Turkey. Their devices are listed in the EU’s eudamed database, which is the official registry for medical devices authorised under EU regulations. This database helps healthcare professionals and regulators verify the manufacturer and device details.

Plasti-med’s devices fall into EU medical device classes I, IIa, and IIb, depending on their risk level and intended use. Class I devices generally pose the lowest risk (e.g., some single-use items like anaesthesia masks), while Class IIa and IIb devices involve higher risks (e.g., wound therapy systems or pulmonary resuscitators) and require additional safety assessments before authorisation.

The provided data does not specify whether Plasti-med’s devices are authorised or marketed outside the EU. However, since they are registered in eudamed, their devices are at least authorised for use within the European Economic Area (EEA). For other regions, compliance with local regulations (e.g., FDA in the US, TGA in Australia) would be required independently.