Certification

All our products are made in the Czech Republic and their high utility value will ensure their long-term and trouble-free use. We work exclusively with quality tested materials manufactured in the EU.

 


HANDKERCHIEFS AND SCARVES

Certifikace rouškaRouška prohlášení CE

 


ASSURANCE

issued pursuant to Art. 13 para. 5 of Act No. 22/1997 and its amendments, and in particular Commission Recommendation EU 2020/403 of 13. march 2020

In accordance with the above law and recommendation, we issue this assurance that the product manufactured by us has been issued a declaration of conformity, which has been prepared on the basis of the test reports of the materials used. 

Medical product:

  • AGTIVE® NANO drape

in accordance with the following derived types:

  • AGTIVE® FIX NANO drape
  • AGTIVE® NANO scarf
  • NANO drape AGTIVE® SPORT
  • NANO scarf AGTIVE® SPORT

The product meets all requirements according to EN 14683 + AC.

The product has passed the health assessment of the SZU dated 9.10.2020 CTZB No. 187-10478/20-191-193 as safe.

The products have been designed, manufactured and approved in accordance with the aforementioned laws, directives and ČSN EN standards and meet the requirements for the CE mark.

It has been tested according to ISO 10993-5 and the materials, nano-substances and nanofilter used are bacteriologically and cytotoxically safe and according to our recommendations are safe for users .


FILTERS

Certifikace FILTR


The effectiveness of the Nano Med Clean filter against viruses has been certified (VFE - Viral Filtration Efficiency) by the respected Nelson Labs in the USA. It is a thin textile containing a nanofibrous structure. Users can put it in a cloth drape to protect themselves all day long. It is lightweight and highly breathable, making it easier to breathe. Compared to other materials, it achieves a breathability of two hundred litres of air per square metre per second.

All production takes place in the Czech Republic. The period of effectiveness of the material is set at 12 hours. Compared to the competition, it differs above all by its high level of breathability, namely 200 l/m²/s.
Nanofilters are designed for insertion into textile drapes. The filter has CE certification and is listed at SÚKL as an accessory of the medical device.
In the link you will find the VFE, BFE and PFE protocols from Nelson Labs and the Declaration of Conformity (CE).
NANO filtrace

CLOTHING


Thegarments and multi-purpose underwear marketed by us meet the conditions of the methodological recommendation No. 1/2000 for garments that come into direct contact with the human body through the skin, comply with the relevant regulations and are safe in compliance with the established recommendations.

 

NANOSHOP s.r.o.
Příkop 843/4
60200 Brno
Czech republic
Business Reg. No.: 09810994
VAT ID: CZ09810994
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