hypoxbreath®
Made in Germany
hypoxbreath®
Made in Germany
The products in our hypoxbreath® med device series have approval as medical devices according to the latest MDR guidelines.
The products in our hypoxbreath® med device series have approval as medical devices according to the latest MDR guidelines.
We subject our production and equipment to the strictest quality and production standards.
Approval for medical devices is only granted to those who can demonstrate multiple redundant failure mechanisms in not only one component or process but in all component connections and control processes and can prove them under endurance tests.
The products in our hypoxbreath® med device series have approval as medical devices according to the latest MDR guidelines.
Even as a buyer of a non-medical device you benefit from these strict production standards, which are standard in our company.
Our quality and safety promise to you:
Our quality and safety
promise to you:
All hypoxbreath® devices are built according to these strict medical standards and thus meet the safety requirements that are placed on clinical devices.
Certified according to the strictest production and safety standards
Certified according to the strictest production and safety standards
Production is carried out by a strong German medical device manufacturer: Telmed Medizintechnik GmbH. Telmed Medizintechnik GmbH’s many years of experience, including its own research and development department with the highest, “Made in Germany” production standards, guarantee the best product quality.
All installed components have specially certified suppliers from Germany and the European area. Critical components that are subject to special safety requirements are produced accordingly in the clean room.
The procurement of other key elements, such as the SpO2 sensor, the O2 sensor, the valve technology, and much more, is also treated with the same care.
All suppliers are subjected to an annual quality and production audit.
Our quality management system is successfully recertified each year. Since 2003, we have consistently met the strict requirements of the DIN EN ISO 9001 standard and the ISO 13485:2016 standard for medical devices.
The hypoxbreath® med is manufactured in line with the new MDR guideline and its requirements in accordance with EU 2017/745.
hypoxbreath® & hypoxbreath® advanced
hypoxbreath® med & hypoxbreath® med advanced