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.
| CND | GMDN | |
|---|---|---|
| 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 |