Certificates

• EasyOne Air
• Easy on-PC
• EasyOne Pro LAB
• EasyOne Pro
• EasyOne Connect
• DLCO Barriettes
• FRC Barriettes
• Spirette mouthpiece
• FlowTube mouthpiece
• EasyOne Filter
• General

EasyOne Air

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

  • EN 146.37 KB

• EasyOne Air, EU Declaration of Conformity

  • Download 448.78 KB

Easy on-PC

• Easy on-PC, EU Declaration of Conformity

  • Download 450.80 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 1.61 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 1.61 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

DLCO Barriettes

• Barriette DLCO and FRC, EU Declaration of Conformity

  • EN 433.27 KB

FRC Barriettes

• Barriette DLCO and FRC, EU Declaration of Conformity

  • EN 433.27 KB

Spirette mouthpiece

• Breathing Mouthpieces (Spirette, EasyOne FlowTubes), EU Declaration of Conformity

  • Download 417.21 KB

FlowTube mouthpiece

• Breathing Mouthpieces (Spirette, EasyOne FlowTubes), EU Declaration of Conformity

  • Download 417.21 KB

EasyOne Filter

• EasyOne Filter SP & FT_EU Declaration of Conformity

  • Download 414.45 KB

General

• Breathing Tubes, EU Declaration of Conformity

  • Download 457.73 KB

• Spiro-SP, EU Declaration of Conformity

  • Download 452.97 KB

• MDSAP Certificate

  • Download 429.93 KB

• General, TÜV Süd, ISO 13485-2016

  • EN 347.57 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

• Information Security, LL-C, ISO/IEC 27001:2022

  • Download 2.36 MB

Other products #

Certificates for the following products are available by request only. Please email [email protected] for a copy.

• EasyOne
• EasyWare
• Easy on-Desk
• EasyOne Air Cradle
• Others