2020-04
COMPLIANCE
To sustain the highest level of quality management and legal compliance demands a strict self-monitoring
security system. We are therefore also 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.
OUR MEDICAL DEVICE CERTIFICATE PORTFOLIO:
ISO13485:2016 Quality Management System, Cert. no. Q5 067759 0027
EC certificate Class IIa, IIb or III MDD, Annex II excluding (4), Cert. no. G1 067759 0028 EC certificate Class IIa, IIb
or III MDD, Annex V, Cert.no. G2 067759 0023
EC certificate Class Is Sterile Devices MDD, Annex V, Cert. no. G2S 067759 0029
OUR ENVIRONMENTAL & QUALITY CONTROL CERTIFICATE PORTFOLIO:
EN ISO14001:2015 Environmental Management System cert. for both our First Aid and Garment manufacturing
site Cert. no. 12 104 36534 TMS
ISO 9001 :2015 for Design, Development, Production and Distribution of First Aid Kit, Plaster, Dressing and
Reflective Products Cert. no. QS5 067759 0031
USA: FDA Registration No. 10027255
AUSTRALIA: TGA Registration No. DV-2013-MC-02343-1
CHINA: Zhejiang, China Registration No. 20130054
OUR COSMETICS PRODUCTS ARE BOTH PRODUCED 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.
SOCIAL COMPLIANCE PROGRAMS
Our factory complies with CSR programs audited / certified by Amfori (BSCI) and SEDEX.
QUALITY CONTROLE CERTIFICATION
Our factory is furthermore audited / certified by BRC Global Standards.
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 Europe (USA and Australia).
NOTIFYING BODY
All our ISO certificates are issued by TÜV SUD.
EC-REP. RFX+Care International A/S Bakkegaardsvej 408, DK-3050 Humlebaek
Printing errors, typesetting errors and others reserved.
All information without guarantee.