Er-med Tıbbi cihazlar Ticaret Limited Şirketi

Er-med Tıbbi cihazlar Ticaret Limited Şirketi specializes in intravenous administration products. Their most common devices include extension sets with integrated filters (such as 1.2µm and 0.2µm filters), multi-lumen venous valves, and total parenteral nutrition (TPN) bags and compounding sets. These products are designed for sterile preparation and administration of intravenous medications, including TPN solutions.

The company is based in Turkey. This location is relevant for regulatory purposes, as it may influence compliance requirements and market access for their devices.

Er-med’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing is required for devices placed on the EU market, ensuring transparency and traceability under EU regulations.

Er-med’s devices fall into Class I and Class IIa categories under EU regulations. Classification is determined by factors like the device’s intended use, risk level, and interaction with the body. For example, extension sets and venous valves are typically Class I or IIa, while TPN bags and compounding sets may also fall into these classes due to their role in sterile drug administration and potential risks if misused.