3 ® TUVRheinland fe 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices Registration No.: HD 60110424 0001 Report No.: 15073585 004 Manufacturer: Neusoft Medical Devices Co., Ltd. Neusoft Park Hun Nan Industrial Area Shenyang 110179 Liaoning China Products: Medical Devices (see attachment for products and additional site included) Replaces Approval, Registration No.: HD 60098956 0001 Expiry Date: 2019-11-07 The Notified Body hereby declares that the requirements of Annex Il, excluding section 4 of the directive 93/42/EEC have been met for the listed products. The above named manufacturer has established and applies a quality assurance system, which is subject to periodic surveillance, defined by Annex II, section 5 of the aforementioned directive. For placing on the market of class Ill devices covered by this certificate an EC design-examination certificate according to Annex I, section 4 is required. Effective Date: 2016-06-12 Date: 2016-06-12 TOV Rheinland LGA Products GmbH - TillystraBe 2 - 90431 Nurnberg TOV Rheinland LGA Products GmbH is a Notified Body according to Directive 93/42/EEC concerning medical devices with the identification number 0197.® TUVRheinland TUV Rheinland ocean "emai LGA Products GmbH TillystraBe 2, 90431 Niirnberg Attachment to Certificate Registration No.: © HD 60110424 0001 Report No.: 15073585 004 Manufacturer: Neusoft Medical Devices Co., itd. Neusoft Park Hun Nan Industrial Area Shenyang 110179 Liaoning China Products: - Computed Tomography Scanner systems - X-Ray Imaging systems - Magnetic Resonance Imaging systems - Diagnostic Ultrasound systems - Diagnostic X-ray High Voltage Generators Site included: Neusoft Medical Devices Co., Ltd. No, 16 Century Road, Hun Nan New District, Shenyang 110179, P-R. China Design and Development, Manufacture of Magnetic Resonance Imaging Systems Date: 2016-06-12