July 07, 2026

Reliable pressure control for tomorrow's medical technology

Kendrion’s Pure Flow Pressure Regulator 48.3 helps medical device manufacturers on the path to MDR readiness. Regulatory demands for medical technology are continually intensifying. The European Medical Device Regulation (MDR), along with standards such as DIN EN ISO 10993, 15001, and 18562, is making the development, documentation, and approval processes for new medical devices increasingly complex. Kendrion's Pure Flow Pressure Regulator 48.3 offers a tailored solution for medical applications, enabling manufacturers to accelerate qualification processes and reduce overall development times.

For medical device manufacturers, regulatory readiness begins well before product completion. It involves carefully selecting components and materials, manufacturing under controlled conditions, and maintaining comprehensive technical documentation. This is where the Kendrion Pure Flow Pressure Regulator 48.3 comes in. Developed for precise control of medical gases, the Pure Flow Regulator 48.3 is suitable for use in ventilators, analytical instruments, anesthesia equipment, and dental technology. The development process considered relevant medical standards and incorporated suitable materials for medical use. In addition to medical gases, the pressure regulator can also be used in fluid applications, such as in dialysis systems. Manufacturing takes place under controlled environments to ensure high standards of quality and cleanliness.

Kendrion offers MDR-ready pressure control

Kendrion's Pure Flow Pressure Regulator 48.3 is designed to assist medical device manufacturers from the initial product development phase, through improvements to existing devices, and during the replacement of pressure regulators. The regulator was developed to address increasing requirements for safety, materials, and technical documentation, helping reduce qualification and integration effort.

"For many medical device manufacturers, the regulatory challenge no longer starts with the device itself but with selecting the right components. With the Pure Flow Pressure Regulator 48.3, we help our customers address regulatory requirements early and reduce development risks," says Sven Desens, Head of Fluid Technology at Kendrion.

Precise pressure control for demanding medical applications

Beyond regulatory considerations, the Pure Flow Pressure Regulator 48.3 stands out for its compact design. Measuring just 30 × 30 × 46 mm and weighing approximately 40 g, it can be easily integrated into a wide variety of medical device concepts. The regulator reduces inlet pressures of up to 10 bar to a consistent, adjustable outlet pressure, providing a stable supply of medical gases.

“In sensitive applications such as analytical or medical technology, precise regulation with high repeatability is critical. This is where our diaphragm pressure regulators really stand out,” says Florian Falk, Product Expert Life Science & Medical at Kendrion.

The pressure regulator is designed for low- to medium-flow rates and delivers precise pressure control with high repeatability. By combining materials suitable for medical applications, controlled manufacturing processes, and comprehensive technical documentation, OEMs can reduce development effort and product costs. The Pure Flow Pressure Regulator 48.3 marks the first product in Kendrion's Pure Flow Line, a carefully developed family of components tailored to meet the needs of medical technology. Kendrion aims to provide reliable, regulatory-ready components for medical device manufacturers.