GCE Medical Achieves MDR Certification for Gas Stabilizer!

25 Apr 2025
Manifolds & Stabilizers
Manifolds & Stabilizers
Martin Panuska Headshot
Author:LinkedinMartin Panuška TimeRead time:3 mins
1 Tag:Regulatory
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Yet another milestone for GCE Medical. Our gas stabilizers have officially received MDR certification! This is a huge step forward in our mission to provide safe, reliable, and high-performance medical gas solutions.

What is MDR?

MDR stands for Medical Device Regulation, a set of strict standards established by the European Union to ensure that medical devices meet the highest levels of safety, quality, and performance. It requires comprehensive testing, quality control, and documentation, ensuring that products are fully compliant with global healthcare regulations.

Why is MDR Certification Important?

MDR certification is a mark of excellence. It means that our gas stabilizer has been rigorously tested and proven to meet the most demanding safety and quality standards in the medical field. This certification is crucial, especially in applications where precise gas pressure control is essential for patient safety.

The ability to meet these regulations further validates our commitment to delivering products that healthcare professionals can trust.

Our Certified Stabilizer

MC150 Stabilizer: A second-stage pressure reduction unit designed to stabilize pressure in hospital gas systems. It ensures reliable performance from high-pressure gas manifolds like MC80, MM90, or liquid oxygen tanks. Features include alarm integration and pressure monitoring options, all in compliance with EN ISO 7396-1 standards.

MC80 Stabilizer: Like the MC150, the MC80 stabilizer ensures stable gas pressure for hospital systems, with easy-to-integrate alarms and pressure monitoring. It meets all the regulatory standards required for medical gas delivery systems.

MM40 Stabilizer: Another second-stage reduction unit, the MM40 stabilizer helps maintain optimal pressure in hospital systems. It includes alarm integration and complies with EN ISO 7396-1, ensuring safe and consistent gas delivery.

Line Regulator: This regulator ensures that gas pressures are adjusted and stabilized before reaching the hospital's terminal units, making it especially useful for areas requiring higher supply pressure. It plays a crucial role in maintaining safety and efficiency across hospital departments.

A Growing Portfolio of Certified Products

These stabilizers join our previously MDR-certified cylinder valves and flowmeter. By achieving MDR certification for these products, we're not just meeting industry standards but setting a new benchmark for performance and safety.

Our Commitment to Excellence

At GCE Medical, we are always committed to ensuring that our entire product portfolio meets the highest standards. Achieving MDR certification for our stabilizer is another huge step in this ongoing journey. We will continue working towards certifying all our products to provide healthcare professionals with the safest, most reliable medical gas solutions available.

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Martin Panuska Headshot
Author:
LinkedinMartin Panuška

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