hypoxbreath®-
Made in germany
hypoxbreath®-
Made in germany
Our hypoxbreath®-med device series has medical device approval in accordance with the latest MDR directive.
Our hypoxbreath®-med device series has medical device approval in accordance with the latest MDR directive.
We subject our production and our appliances to the strictest quality and production standards.
Medical device approval is only granted to those who can demonstrate multiple redundant failure mechanisms in not just one component or process, but in all component connections and control processes, and can prove this in endurance tests.
Our hypoxbreath®-med device series has medical device approval in accordance with the latest MDR directive.
As a buyer of a non-medical device, you also 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 to these strict medical standards and therefore meet the safety requirements placed on clinical devices.
Certified to the strictest production and safety standards
Certified to the strictest production and safety standards
Production is carried out by a strong German medical device manufacturer: Telmed Medizintechnik GmbH, whose many years of experience, including the company’s own research and development department with the highest production standards “Made in Germany”, guarantee the best product quality.
All installed components are sourced from certified suppliers in Germany and Europe. Critical components, which are subject to special safety requirements, are produced in a clean room.
Other key elements, such as the SpO2 sensor, O2sensor, valve technology, etc., are treated with the same care. .
All suppliers are subject to an annual quality and production audit.
Our quality management system is successfully recertified every 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 according to the new MDR directive and its requirements in accordance with EU 2017/745.
hypoxbreath® & hypoxbreath® advanced
hypoxbreath®-med& hypoxbreath®-med advanced