EC CERTIFICATENumber: 66692CE01 Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding (4) 12011 Mosteller Road Cincinnati, OH 45241 United States of America DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to. accompany the CE Marking of Conformity on the products concerned conforming to the required Technical' Documentation and meeting the provisions of the EC-Directive which apply to them: Documents that form the basis of this certificate: Certification Notice 66692CN, initially dated 5 June 1997 Addendum, initially dated 3 June 2003 DEKRA hereby declares that the above-mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14,1993 concerning Medical devices, including all subsequent amendments. The manufacturer has implemented a quality assurance system for design, manufacture and final inspection for the above-mentioned product category in accordance to the provisions of Annex II of Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance For placing on the market of Class III devices an additional EC design examination certificate according to Annex II (4) is mandatory The necessary information related to the quality management system of the manufacturer, including facilities and the reference to the relevant documentation of the products concerned and the assessments performed are stated in the Certification Notice, which forms an integrative part of this certificate. This certificate is valid until: 1 December 2023 Issued for the first time: 5 June 1997 B.T.M. Holtus Managing Director © Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344 DEKRA Certification B.V. Meander 1051. 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 B3000 F +31 88 96 83100 www.dekra-product-safety.com Company registration 09085396

ADDENDUM > DEKRA Belonging to certificate: 66692CE01 MEDICAL DEVICES Electromedical Devices for Convective Air Therapy Gentherm Medical LLC 12011 Mosteller Road Cincinnati, OH 45241 United States of America This certificate covers the following prcduct(s): WarmAir Units (Class lib) Initial date: 3 June 2003 B.T.M. Holtus Managing Director © Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344 DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netheriands T+31 B8 96 83000 F+31 88...

P DEKRA Number: 66692CE02 Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding (4) 12011 Mosteller Road Cincinnati, OH 45241 United States of America IiflElectromedical Devices for Water-Based Hyper/Hypothermia Heater/Cooler Equipment DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany the CE Marking of Conformity on the products concerned conforming to the required Technical' Documentation and meeting the provisions of the EC-Directive which apply to them: Documents that form the basis of this certificate:...

ADDENDUM Belonging to certificate: 66692CE02 Electromedical Devices for Water-Based Hyper/Hypothermia Heater/Cooler Equipment 12011 Mosteller Road Cincinnati, OH 45241 United States of America This certificate covers the following product(s): Water-Based Hyper/Hypothermia Units (Class lib) Initial date: 3 June 2003 B.T.M. Holtus Managing Director J.A. van Vugt Certification Manager © Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344 DEKRA Certification B.V. Meander 1051,6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem,...

Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding (4) 12011 Mosteller Road Cincinnati, OH 45241 United States of America DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany the CE Marking of Conformity on the products concerned conforming to the required Technical Documentation and meeting the provisions of the EC-Directive which apply to them: Documents that form the basis of this certificate: Certification Notice 66692CN, initially dated 5 June 1997 Addendum, initially dated 3 June 2003 DEKRA hereby declares...

> DEKRA Belonging to certificate: 66692CE03 CE MARKING OF CONFORMITY MEDICAL DEVICES 12011 Mosteller Road Cincinnati, OH 45241 United States of America This certificate covers the following produces) Air Hyper/Hypothermia Blankets (Class Mb) Initial date: 3 June 2003 Managing Director Certification Manager © Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344 DEKRA Certification B.V. Meander 1051,6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T+31 88 96 83000 F+31 88 96 83100 www.dekra-product-safety.com...

Directive 93/42/EEC on Medical devices, Annex II excluding (4) (Devices in Class lla, lib or III) 12011 Mosteller Road Cincinnati, OH 45241 United States of America Water Hyper/Hypothermia Blankets the CE Marking of Conformity on the products concerned conforming to the required Technical Documentation and meeting the provisions of the EC-Directive which apply to them: Documents that form the basis of this certificate: Certification Notice 66692CN, initially dated 5 June 1997 Addendum, initially dated 3 June 2003 DEKRA hereby declares that the above-mentioned manufacturer fulfils the relevant...

MEDICAL DEVICES ADDENDUMWater Hyper/Hypothermia Blankets Issued to: 12011 Mosteller Road Cincinnati, OH 45241 United States of America This certificate covers the following product(s): Water Hyper/Hypothermia Blankets (Class lib) Initial date: 3 June 2003 B.T.M. Holtus Managing Director © Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344 DEKRA Certification B.V. Meander 1051,6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T+31 88 96 83000 F+31 88 96 83100 www.dekra-product-safety.com Company registration...