Documentation and accreditations

NCN MR2 template is registered:

  • to the Italian Ministry of Health as a class 1 medical device with repertoire number 1929079 and CND code R030199 “Other Respiratory Masks”, according to Regulation 2017/745 / EU
  • to the Romanian Ministry of Health as a class 1 medical device with repertory number 5088 / 09.07.2020

In the attachments you can see how this innovative treatment based on carbon nanoclusters determines a high bacteriostatic and virucidal activity against new generation viruses such as Covid 19.

 

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Secondary documentation

The NCN MR2 face mask is made of ICEA certified organic cotton fabric. ICEA certification is known for evaluating the entire production chain of a given product, therefore organic cotton is not treated with heavy chemical additives as it normally happens. The guarantee of being able to wash the NCN MR2 mask in water is determined precisely by the manufacture in organic cotton and by the protection through the new patent based on groupings of carbon atoms. Carbon atoms which in nano-metric form are deposited on the organic cotton thus creating a protection of the highest level and lasting precisely for 30 washes.

The NCN MR2 cloth face mask is therefore particularly comfortable for daily and frequent use. It does not create irritation or allergies and helps allergic people to breathe thanks to the filtration of allergens.

Finally, the washability guarantee for 30 times determines a very advantageous cost in use compared to a guarantee of maintaining the expected protection characteristics, lasting in an optimal way. So for a whole month even in conditions of intensive daily use.

FAQ

What medical classification does it have?

Our intent has always been to create a medical device that would stand out on the market. Thus, the registration code that the Ministry accepted, which is, “R 03 01 99 – Maschere Respiratorie Altre” (Respiratory Masks Others) perfectly classifies our product:

  • R: “Respiratory System and Anesthesia Devices
  • 03: “Disposable and Multi-purpose Masks and Bag valve masks
  • 01: “Respiratory Masks
  • 99: “Respiratory Masks – Others

Is it a Medical Device or a Personal Protective Device?

The NCN MR2 mask is a Class 1 reusable and non-sterile medical device that is registered at the Ministry of Health as number 1929079 upon providing and verifying an appropriate “Technical File”.

The NCN MR2 mask IS NOT a Personal Protective Device (DPI), meaning it does not have any of the characteristics to be identified with the FFP (FFP1, FFP2, FFP3) classification. Thus, it does not have the necessary accreditation for these devices.

Finally, the NCN MR2 mask falls into the category of devices that are “useful for preventing the spread of potentially infected organic droplets” and can be used by everyone in an external environment and by all involved in work activities (law enforcement officers, employees in offices open to the public, logistic employees, grocery store employees, GDO, etc) and by medical and paramedical personnel who DO NOT work in sterile environments.

TORNA SU