epee cr eo $ Business Stream Products Certification Department TOV Pend UGA Proce Grit 90431 Norberg ‘Shenyang RMS Medical Tech Co., Ltd No. 21, Gaoke Road, Hunnan District Shenyang 110179 LIAONING CHINA Application for _: Vollst. QMS, Anhang II MDD Certificate No. : HD 60139641 Sheet 0001 Device Only for QM-System audit Test requirement : Richtlnie 99/42/EWG Dear Madame or Sir, Enclosed please find the new certificate No. HD 60139641 0001 Tepiacing the previous certificate Kind regards Certification body S. Liu Pagty Test sample: no, documentation available TOVRheinland® LGAM Precisely Right. contact Tol +40 911685 5225 Mai serce@éetw.com Date June 03,2010 ‘TOV Rneiians UGA Produce Get Tuystrae2 90431 Number Tet +4991) 685.5225 Mak servcegde tv com Web va tv coat ‘Board ot Management tng {ore Marler, Spokesman ktm rst Seteser Charman ofthe Suponsery Bout DpLtng a Senator Nuremberg HRB 26013 ‘VAT No: DE 611835490EC Certificate TUVRheinland Directive 93/42/EEC Annex II, excluding Section 4 Full Quality Assurance System Medical Devices Registration No.: HD 60139641 0001 Report No.: 16803290 008 Manufacture! Shenyang RMS Medical Tech Co., Ltd. No. 21, Gaoke Road, Hunnan District Shenyang 110179 Liaoning China | Products: - Sleep Apnoea Breathing Therapy Systems = Medical Oxygen Concentrators - Full-face Masks - Nagal Masks | - Breathing Tubes - High-flow Heated Respiratory Humidifiers Replaces Approval, Registration No.: HD 60134036 0001 Expiry Date: 2024-05-27 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 Il, section 5 of the aforementioned directive. For placing on the market of class. Effective Date: 2019-06-03 Date: 2019-06-03 TUV Rheinland LGA Products GmbH - Tillystrae 2 - 90431 Niirnberg TUV Rheinland LGA Products Gmbt ‘@ Notified Body according to Directive 93/42/EEC concerning medical devices with the identification number 0197.