Medical Devices certifications in Italy, the European Union and extra EU Countries.

MD S.r.l. as a manufacturer of medical devices has implemented a quality control system in compliance with norm UNI EN ISO 13485 – 2004.

Further, in compliance with the requirements of Directive 93/42/CEE – Annex II – Paragraph 3 MD S.r.l. is authorised by notified body ITALCERT (0426) to use CE 0426 marking on the Medical Devices it manufactures

According to the new compliace modalities of article 13 of the Legislative Decree dated 24th February 1997 n° 46 and further modifications, the registration in the register for Medical Devices, the abvoe mentioned components are classified according with the codes of CND national classification and GMDN Global Medical Device Nomenclature. The Medical Devices manufactured by MD srl are also of free sale and circulation and can be sold in Italy, the European Union territory and exported to extra EU territories, according to the free sale certificate issued by the Innovation Department – General Direction of Drugs and Medical Devices of the Italian Health Ministry.

Terminal units for the distribution of medical gases and vacuum; Z120309 36124
In-line pressure regulators for the distribution of medical gases; Z120309 47560
Anesthetic gas scavenging terminal units; Z1203010180 34849
Flowmeters and humidifiers for the dosing of medical gases; Z12159099 37132
Vacuum regulators for medical use; Z12019080 44809
High pressure flexible connections; Z120309 47560
High pressure manifolds; Z120309 47560
Automatic change-over decompression stations, emergency decompression stations; Z120309 47560