Medax quality management system is certified to ISO13485:2016 standards, in accordance with the requirements of the medical disposable 93/42/CEE directive and its relevant updates. All products undergo intensive clinical testing and are CE and FDA approved.
Focused as it has always been on worldwide markets and with a strong experience in products’ registration processes, our Regulatory department is ready to help our customers’ needs and constitutes a steadfast support during the developing of new and customized products
For any further documents, please contact our Regulatory Affairs at Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.
MEDAX S.R.L. Unipersonale
Via Sandro Pertini, 4 - 41039 - San Possidonio (MO) - Italy
Company direct No. : +39 0535 1812757 - Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.
Vat N. /Fiscal Code N. Iscriz. Reg. Impr. 02669860369 - N. REA: MO 403036 - Capitale Sociale Euro 100.011,00 i.v.
In accordance with the requirements of the medical device 93/42/EEC directive and its relevant updates. All products undergo intensive clinical testing and are fully EC and FDA approved.