The EC Certificate of Conformity
The EC Certificate of Conformity is an important document for production, located in the European Economic Area market.
The Certificate of Conformity is a legal document, which confirms the conformity of the product to EU standards.
Granting the certificate is accompanied with getting the CE mark, which is mandatory.
CE mark (an abbreviation of fr. ConformitéEuropéenne – European Conformity) is found on a product and confirms, that a product complies with EU directives and EU standards, and also indicates that the conformity assessment procedure has been carried out accordingly.
CE marking indicates, that a product is safe for the health of its consumers, and also that is not harmful to the environment. The CE mark is the only mark in the EU countries, which confirms the conformity of the production to EU standards of human safety, property and environment.
The receipt of a Certificate of Conformity is not mandatory, but it makes a product more competitive, demonstrates attention to quality and gives confidence about quality for those, who use it. To sell a product like this is a pleasure for distributors. The final consumer is also satisfied.
The Certificate is granted for 3 years, which also means that experts have reviewed the production and accept it is excellent and solid.
The Certificate of Conformity, received by Cryomed s.r.o. for the newest model of cryosauna, Cryomed PRO is an acknowledgment of our achievements and a confirmation of our experience.
Cryomed PRO complies with:
ЕС Machinery Directive
Electromagnetic Compatibility (EMC) Directive
EC Certificate – Full Quality Assurance System No. 18 0491 QS/NB
Our new device – Cryomed Pro M – has been certified as meeting the requirements of Directive 93/42/EEC on medical devices, Annex II excluding (4) and is now officially a Medical Cryotherapy Device class 2B.
This means that Cryomed Pro M is now available to the medical industry (hospitals, private clinics, etc.) in some EU countries.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Cryomed became the only manufacturer of cryogenic devices in the world who complies with all these requirements! The issuing body – TÜV Rheinland.
Annex II: Full Quality Assurance System
Annex II: Full Quality Assurance System – This conformity assessment includes a review of the manufacturer’s entire quality management system that includes design, manufacturing, and final inspection. Cryomed have received a certificate of conformity to the provisions of this conformity assessment. The issuing body is one of the most reputable in the area – TÜV Rheinland.