Manatec Biomedical Headquarters : 21, rue du stade Petit Ebersviller ▪ 57730 FOLSCHVILLER ▪ France tel : +33 3 73 82 50 00 ▪ fax : +33 1 30 74 46 48 [email protected] EC DECLARATION OF CONFORMITY - DIRECTIVE 93/42/EEC We, MANATEC 21 RUE DU STADE PETIT-EBERSVILLER 57 730 FOLSCHVILLER FRANCE, hereby certify that the PhysioFlow devices (devices of class IIa according to the rule 10 of the appendix IX of the EC Directive 93/42/EEC, devices whose list can be found in the attached appendix), non-invasive medical devices for hemodynamic measurements by transthoracic impedance signal analysis, are in conformity with the book Vbis L665-4 of the French Public Health Code and the decree 95-292 of March 16th 1995 which concerns those products (decree transposing the EC Directive 93/42/EEC into the French national legislation). This declaration is based on the following elements: ▪ Technical files, established in accordance with the appendix II section 3.2(c) and demonstrating the conformity of the product to the standards of the Directive 93/42/EEC and in particular to the Essential Requirements (see reference for each product in attached appendix) ▪ EC certificate 11826 of approval of the full Quality Assurance System in accordance with the appendix II section 3 of the Directive 93/42/EEC and granted by the notified body GMED, identification number N°0459 (1 rue Gaston Boissier – 75 724 PARIS cedex 15, FRANCE) In Petit-Ebersviller, July 1st 2021 Benoît Bosquet – Co-Manager Manatec Biomedical ▪ SARL au capital de € 30 000 ▪ R.M. : 402 547 574 RM 57 ▪ Siret 402 547 574 000 10 ▪ APE 3250A ▪ 21, rue du Stade 57730 PETIT-EBERSVILLER Manatec et Physio Flow s

Manatec Biomedical Headquarters : 21, rue du stade Petit Ebersviller ▪ 57730 FOLSCHVILLER ▪ France tel : +33 3 73 82 50 00 ▪ fax : +33 1 30 74 46 48 [email protected] EC DECLARATION OF CONFORMITY - DIRECTIVE 93/42/EEC APPENDIX : LIST OF THE PHYSIOFLOW PRODUCTS concerned by the EC Declaration of Conformity Device designation PhysioFlow PF07 Enduro PhysioFlow PF07 Q-Link Device commercial name or article code PhysioFlow Enduro PhysioFlow Q-Link Technical file reference PF07 Enduro PF07 Q-Link Benoît Bosquet – Co-Manager Manatec Biomedical ▪ SARL au capital de € 30 000 ▪ R.M. : 402 547 574 RM...