Quality and regulatory certificates

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Certificates

Quality Management System: ISO 13485:2016 & EN ISO 13485:2016

Quality Management System: Directive 93/42/EE on Medical Device, Annex II excluding Section 4

Quality Management System: ISO 13485:2016; MDSAP

Declarations

Declaration of Conformity – TGA

Declaration of Conformity – SOZO

Declaration of Conformity – Electrodes

Declaration of Conformity – L-Dex U400

Declaration of Conformity – SFB7

Regulatory clearances

510(k) clearance K050395 – DF50 Body Composition

July 2005

510(k) clearance K052319 – SFB7 Body Composition

April 2006

510(k) clearance K130338 – U400 L-Dex

May 2013

510(k) clearance K172507 – SOZO Heart failure

December 2017

510(k) clearance K180126 – SOZO L-Dex

April 2018