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Certification

md s.r.l. as a medical devices manufacturer has implemented a quality management system compliant with EN ISO 13485:2004.

Moreover, in compliance with requirements stated in 93/42/EEC Directive, Annex II, Paragraph 3, md s.r.l. is allowed by the notified body ITALCERT (0426) to put CE marking on the following Medical devices:

 

CND GMDN

Terminal units for medical gas and vacuum

120309 36124
Line pressure regulators for medical gas pipeline systems
Z120309 47560
Terminal units for anaesthetic gas scavenging systems
Z1203010180 34849
Flow meters and humudifiers for medical gas administering
Z12159099 37132
Medical vacuum regulators
Z12019080 44809

MD medical devices are classified according to the Global Medical Device Nomenclature (GMDN) as in the table above.

Medical devices produced by MD Srl can be traded and sold in the whole European Union territory and can be exported to extra_EU countries, according to the free sale certificate released by the italian Department of Innovation (Ministry of Health).

 

Quality System ISO 13485 iconapdf
Quality System ISO 9001 iconapdf
CE Marking / 93/42 Directive
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Annex
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Free Sale
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