The PulsePen is CE marked and certified as class IIa Medical Device according to the Annex IX chapters I and III of the Regulation (EU) 2017/745, number 119/MDR.
The Quality Management System of DiaTecne s.r.l. is ISO 13485 certified with the number 0857.2023
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.