MedNet GmbH

•  wide range of sizes  •  material selections to support diverse applications   •   medical compliance
 
Münster 2020/08/02 - MedNet, supplier and manufacturer of medical and pharmaceutical components, expands its comprehensive portfolio of tubing with additional materials and configurations. Beside an increased range of tube sizes, the portfolio now covers materials including Silicone, Polyurethane (PU/PUR), Acrolene XPTM (flexible TPE), Linear Low-Density
Polyethylene (LLDPE/PE) and Polyvinyl chloride (PVC).
 
The material selection allows designers to manage key mechanical and chemical properties ranging from shore hardness, flexibility over kink and temperature resistance to bondability. Medical grades can be DEHP or plasticiser free and are suitable for a range of sterilisation procedures.

In specific, the following advantages are given by the different materials:

Silicone
Shore hardness: 58A
This clear, extremely flexible material is resistant against high temperatures. Due to its memory effect (it returns to original form after deformation) it is often be used in pump systems. Our silicone is plasticizer-free. Upon request we can supply silicone tubing with radiopaque stripes and/or colour coding. As the material of our Silicone tubing was tested for USP Standard Class VI and various ISO10.993 standards, it is suitable for use in medical applications. The tubing can be sterilized by autoclave, gamma
radiation and Ethylene Oxide (EtO) gas.

Polyurethane (PU/PUR)
Shore hardness: 85A
Polyurethane is a flexible material distinguished by high mechanical strength and kinking resistance. It is plasticizer-free and is often used for its good bondability.

Acrolene XP™ (TPE)
Shore hardness: 75A
Designed as a polyethylene based tubing with advanced performance capabilities, Acrolene XP™ is not only flexible but highly chemical and temperature resistant. It can be used for a great variety of applications.

Linear Low-Density Polyethylene (LLDPE)
Shore hardness: 44D
LLDPE is a flexible material that exhibits excellent chemical resistance. It is plasticizer-free and cost efficient.

Polyvinyl Chloride (PVC)
Shore hardness: 70A
Our Polyvinyl chloride tubing is a flexible, cost efficient tubing solution providing good bonding performance. It is a DEHP-free material that passed USP VI and Cytotoxicity testing for biomedical devices.

The MedNet tubing as well as various other unsterile components for medical and industrial applications can be found in MedNet‘s online catalog under www.medneteurope.com/components.

MedNet extends its comprehensive portfolio of colour coded syringes with a BPA-free version made from copolyester. TritanTM is a thermoplastic polyester from US-American manufacturer Eastman Chemical that is manufactured without bisphenol A (BPA) and without halogen addition, which is used in place of the conventional polycarbonate. The material is highly transparent and can be sterilized with gamma radiation, electron-beam or ethylenoxid with no change in colour. Having high chemical resistance suitable for many drugs as well as lipid resistance, Tritan is particularly suitable for the environmental conditions required by the modern medtech industry, also for its resistance against stress crack formation and ageing.

MedNet offers the Tritan syringe range in addition to the well established PC (polycarbonate) colour coded syringes. Both versions are available in different volumes from 1ml to 30 ml, with luer lock or luer slip. All syringes are available CE-marked. The syringes are available in seven different plunger colours.

MedNet assumes responsibility for the regulatory support for CE certification of the stopcocks and manifolds from the world market leader Elcam Medical and is now able to
offer them CE marked in non sterile version.

“In the regulatory area, MedNet is well positioned because it has an established workflow and access to the appropriate resources. The certification by MedNet gives us the opportunity to offer our mutual customers in Europe the maximum regulatory support,” explains Amir Bohadana, Sales Executive Director at Elcam Medical, in the decision to outsource the regulatory support to MedNet.

MedNet has sold Elcam components on the European market for more than 30 years. In addition to sales, MedNet has been supporting the registration of international medical devices for the European market for over 20 years and has also launched its own product line in 2013.

With the CE mark on the non sterile component, MedNet is responding to the needs of medical device manufacturers all over Europe, who are faced with higher regulatory requirements coming into effect. Every component of a device or set now requires a technical file, which increases the regulatory effort and the hurdles for innovations. “Small companies don't have the staying power until the registration is completed. Providing CE certificates for individual non-sterile components simplifies the preparation of the product file and significantly reduces the time required for a market launch”, explains Ole Stein, Managing Director at MedNet.

With the purchase of the non sterile CE marked components, medical device manufacturers save the regulatory effort. In addition to time and financial savings, it also increases planning reliability for new developments and sets.

For Custom Procedure Tray providers who in accordance with Article 12 MDD / Article 22 MDR depend on a CE mark for theirs components, the purchase of the non-sterile version saves the additional unpacking / packaging effort and bypasses the problem of a second sterilization in the set compared to the packaged, sterile medical device.

In addition to the Elcam stopcocks and manifolds, MedNet offers various non sterile CE marked components from the field of fluid management as well as for angiography and interventional cardiology / radiology.