To sustain the highest level of quality management and legal compliance demands a strict self-monitoring delivery security system. We are therefore by nature obliged to stay alert with any changes in all required legislations worldwide and keep all our ISO and EC certifications as well as product registrations updated.
In order to comply with the CE regulations for marking and instructions on products placed in the market, it is a neccesity to have all legal text in place. Our legal text database contains all relevant legal text for all our products in 25 languages.
REACH; We are testing our materials in accordance with the European Chemicals Agency according to directive EC/1907/2006. Registrations / Certifications. Our Medical products are CE certified by TUV SUD and can be freely distributed and sold in below mentioned markets.
EUROPE: ISO13485:2012 Quality Management System, Cert. no Q1N 16 09 67759 013
EC certificate Class IIa, IIb or III MDD, Annex II excluding(4), Cert.no. G1 16 09 67759 016
EC certificate Class IIa, IIb or III MDD, Annex V, Cert.no. G2 16 09 67759 014
EC certificate Class Is Sterile Devices MDD, Annex V, Cert. no. G2S 16 09 67759 015
USA: FDA Registration No. 10027255
AUSTRALIA: TGA Registration No. DV-2013-MC-02343-1
CHINA: FDA, Zhejiang, China Registration No. 20130054
Our cosmetics products are produced both in Europe and China.
They all comply with REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products.
We comply with Environmental / Quality control certifications:
ISO14001:2004 Cert. no. 12 104 36534 TMS
ISO 9001:2015 Cert. no. is QS5 17 10 67759 019
We comply with social compliance programs audited / approved by BSCI, SEDEX and BRC