Certifications
Medical Device Certifications in Italy, the European Union, and Non-European Countries
MD S.r.l., as a manufacturer of medical devices, has implemented a quality management system in compliance with the UNI EN ISO 13485:2004 standard.
Furthermore, in accordance with the requirements set out in Directive 93/42/EEC – Annex II – Section 3,
MD S.r.l. is authorized by the notified body ITALCERT (0426) to affix the CE 0426 marking on the medical devices it produces.
In line with the new procedures for compliance with Article 13 of Legislative Decree No. 46 of February 24, 1997, as subsequently amended, for registration in the Medical Device Repertoire, the above-mentioned components are classified according to the codes of the national CND classification and the Global Medical Device Nomenclature (GMDN) described above. Medical devices manufactured by MD S.r.l. are freely circulated and may be marketed in Italy and throughout the European Union, as well as exported to non-European countries in accordance with the Certificate of Free Sale issued by the Department of Innovation – General Directorate of Medicines and Medical Devices of the Italian Ministry of Health.
| CND | GMDN | |
|---|---|---|
| Terminal units for the distribution of medical gases and vacuum; | Z120309 | 36124 |
| Line pressure regulators for medical gas distribution systems; | Z120309 | 47560 |
| Terminal units for anesthetic gas scavenging | Z1203010180 | 34849 |
| Flowmeters and humidifiers for the administration of medical gases; | Z12159099 | 37132 |
| Medical suction devices; | Z12019080 | 44809 |
| High-pressure flexible connections; | Z120309 | 47560 |
| High-pressure manifolds; | Z120309 | 47560 |
| Automatic changeover decompression units, emergency supply units; | Z120309 | 47560 |
