ZEPF MEDICAL INSTRUMENTS® is certified according to ISO 13485:2021 and Annex IX, Chapter I of Regulation (EU) 2017/745, as well as by the confirmation of the Confirmation Letter under Annex II of Directive 93/42/EEC. This guarantees the traceability of our instruments from the finished product to the molten steel. This means that we also fulfill a requirement of the US FDA authority, with which we are registered.

All of our products of course have the CE marking. All products which are higher than Class I are marked with the CE and the number of the “Notified Body “.  Full range of instruments – please email our sales team with your request sales@fitzmedicalsupplies.ie