Certificates

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FAQ

Research, tests, studies and more proof of the AiroDoctor effectiveness

Since April 1, 2021, the AiroDoctor manufacturing facility has been certified according to ISO 13485:2016. The certification is specifically aimed at medical devices and falls within the legally regulated area in Germany to ensure conformity according to the current Directive 93/42/EEC (MDD) as well as the European Medical Device Regulation (MDR). The international certificate represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices and also applies to all future product models based on UV-A photocatalysis.

Yes. The AiroDoctor WAD-M20 was certified to ISO 16000-36:2018 in March 2021 and to ISO 13485:2016 in April 2021.


• ISO 16000-36:2018 evaluates the performance of air purifiers in reducing culturable bacteria in the air.

• ISO 13485:2016 certified the AiroDoctor manufacturing facility. This certification specifically addresses medical devices and ensures conformity to the current Directive 93/42/EEC (MDD) and the European Medicinal Products Regulation (MDR). The international certificate represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices and also applies to all future product models based on UV-A photocatalysis.

Yes. AiroDoctor WAD-M20 was tested in the ISO 16000-36:2018 test chamber procedure in March 2021 and was subsequently certified. This standard procedure evaluates the performance of air purifiers, testing the reduction rate of culturable bacteria in the air. AiroDoctor achieved a reduction rate of 99.9% here. As there is currently no air purifier ISO test procedure for the elimination of airborne viruses such as SARS-CoV-2, further test runs were carried out outside the ISO certification, but in the same test chamber and under the same test conditions. For this, the efficacy of the AiroDoctor was determined on surrogate viruses similar to SARS-CoV-2. Here, too, the AiroDoctor achieved a reduction rate of 99.9%.

Yes. The effectiveness has already been investigated and confirmed in several international studies. You can find the results of the laboratory and real life studies here.

Yes. The AiroDoctor is certified for product safety, mode of action and efficiency, including the CE certification by the German Technical Inspection Agency (TÜV). An overview of all certificates, seals and studies can be found here.

The AiroDoctor was developed in South Korea in 2018 by biochemist Dr. Eddie Kim, now Vice President of AiroDoctor. In 2019, the first prototype was completed and tested. At the beginning of the Corona pandemic, the elimination of airborne viruses and bacteria was scientifically proven in laboratory studies, and the first devices were used in South Korean emergency centers. AiroDoctor has been sold in Germany since April 2020, and worldwide since October 2020. In December 2020, AiroDoctor became an official partner company of the renowned Korea Institute of Civil Engineering and Building Technology (KICT)

Yes, also against mutations of these viruses. Several laboratory analyses and a real-life study commissioned by the Charité university hospital in Berlin clearly came to this conclusion. Here you can find the test report.

Yes. Several laboratory analyses and a real-life study commissioned by the Charité institute in Berlin clearly came to this conclusion. You can find the test report here.

Yes. The HEPA H13 filter of the AiroDoctor meets the requirements according to HEPA filter classes according to EN 1822-1:2009.

The AiroDoctor complies with the Ecodesign Directive 2009/125/EC. The Ecodesign Directive is the European legal framework "for the setting of ecodesign requirements for energy-related products". The AiroDoctor also meets the requirements defined by politicians and scientists for efficient air purification, for example for its use in schools, kindergartens and daycare facilities.

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