Certificates

• EasyOne® Air
• Easy on-PC
• EasyOne Pro® LAB
• EasyOne Pro®
• EasyOne Connect
• General

EasyOne® Air

• EasyOne Air, FDA, 510(k) Letter (USA, approval to market)

  • EN 146.37 KB

• EasyOne Air, EU Declaration of Conformity

  • Download 458.50 KB

Easy on-PC

• Easy on-PC, EU Declaration of Conformity

  • Download 400.95 KB

• Easy on-PC, FDA, 510(k) Letter (USA, approval to market)

  • EN 131.73 KB

EasyOne Pro® LAB

• EasyOne Pro and LAB, EU Declaration of Conformity

  • Download 1.54 MB

• EasyOne Pro / LAB, FDA, 510(k) Letter (USA, approval to market)

  • EN 230.81 KB

EasyOne Pro®

• EasyOne Pro and LAB, EU Declaration of Conformity

  • Download 1.54 MB

• EasyOne Pro / LAB, FDA, 510(k) Letter (USA, approval to market)

  • EN 230.81 KB

EasyOne Connect

• EasyOne Connect, EU Declaration of Conformity

  • Download 484.52 KB

General

• Breathing Tubes, EU Declaration of Conformity

  • Download 398.33 KB

• Spiro-SP, EU Declaration of Conformity

  • Download 452.97 KB

• MDSAP Certificate

  • EN 442.69 KB

• General, TÜV Süd, ISO 13485-2016

  • EN 390.47 KB

• TÜV Süd, EC Certificate, MDD Directive 93-42-EEC (Only valid for EasyOne Pro & LAB)

  • EN 248.20 KB

• TÜV SÜD, EC Certificate, MDR Regulation 2017745

  • EN 301.56 KB