Quality Standards

Quality and Regulatory compliance requirements for Medical Device companies are ever changing and Sterimedix Limited is focussed on ensuring we meet all relevant standards applicable to our business. The Company’s products are registered in all the major markets worldwide. For more information please do not hesitate to contact us.

▸ EN ISO 13485 2016 – Certificate No Q5 105847

▸ MDD 93-42-EEC Annex II – Certificate No G1 105847

▸ MDD 93-42-EEC Annex V – Certificate No G2MS 105847

▸ MDD 93-42-EEC Annex V – Certificate No G2M 105847

▸ MDD 93-42-EEC Annex V – Certificate G2S 105847