Juli 21, 2023
Components

MedNet Expands its Portfolio of Non-sterile CE-marked High Pressure Lines and Pressure Monitoring Lines

MedNet GmbH, an experienced service provider and supplier in the field of medical technology, is expanding its portfolio of non-sterile CE-marked components with a wide range of medical high pressure lines and pressure monitoring lines to meet the special requirements of kit packers and to simplify the handling of regulatory challenges.

For kit packers, the non-sterile CE-marked lines offer two advantages:

(1) Firstly, kit packers benefit from the fact that the CE marking of the lines does not require the conformity assessment in terms of its entirety. The technical documentation is also the responsibility of the component supplier.

(2) Secondly, non-sterile components eliminate the need for time-consuming repackaging of any sterile alternatives. In addition, non-sterile components allow for single-use sterilisation, thereby avoiding regulatory and qualitative risks. Last but not least, kit packers benefit from the lower price of non-sterile products compared to sterile components.

“Our CE-marked non-sterile components save kit packers a lot of regulatory effort, time and costs,” says Ole Stein, Managing Director of MedNet.
The high pressure lines (1200 psi) have been specially developed for cardiology and radiology requirements and are used, for example, for the passage of contrast media and sodium chloride solutions. They are made of DEHP-free PVC or alternatively, fabric-reinforced PUR and are equipped with a female luer lock connector and optionally, with a male luer lock connector or a rotating adapter.

Source: MedNet GmbH