• Home
  • Products
    • PulsePen
    • PulsePenLab
  • News
  • References
    • PulsePen Validation
    • Research Papers
  • Methods
    • Arterial Tonometry
    • Signal Capture
    • Comparison
  • Company
    • History
    • Certification
    • Disclaimer / Privacy Policy
    • Contacts
  • Support
    • FAQ
    • Downloads
    • Support Request





Certification



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.