The PulsePen is CE marked and certified as class IIa medical device according to the Directive 93/42/EEC, Annex II, num. 1878/MDD.
It is recorded in the Italian Health Ministry DataBase with the following number: 1297268.
The Quality Management System of DiaTecne s.r.l. is ISO 13485 certified with the num. 9124.DTCN
CB certificate according to IEC 60601-1 (ed.3): IT-15489
CB certificate according to IEC 60601-1-2 (ed.3): IT-15690
The CB certificates are recorded in the IECEE database, accessible from the IECEE “CBTC Online System” inserting the
related reference number.
