IT@ Notified Body No 1023 INSTITUTE FOR TESTING AND CERTIFICATION, Inc. Zlin, Czech Republic ~ www itczlin.cz EC CERTIFICATE No. 13 0242 QS/NB issued in compliance with the Council Directive 93/42/EEC as amended, which is implemented by the Czech Government Order No. 36/2004 (Collection of Laws), certifies that the product ~ medical device of Class IIb: X-Ray Equipments Models: Allengers-30, Allengers-60, Allengers-100, Allengers-325, Allengers-525, Allscan-uP6, Allscan-P9, Mars 50+ ‘manufactured by company ALLENGERS MEDICAL SYSTEMS LTD. Head Office: SCO 212-214, SECTOR 34-A, CHANDIGARH -1600 22, INDIA Factory(1): Bhankarpur, Mubarkpur Road, Derabassi Distt.- Mohali (140507), india Factory(2}: 183A, HPSIDC Industrial Area (Badd), Distt-Solan(173208) (HP), India is manufactured under conditions fulfiling the quality system requirements of Annex ll, Section 3.2 of the Directive 9342/EEC, as amended ‘The Notified Body No. 1023 has performed an audit of the above products quality system covering the design, manufacture and final inspection of the certified products. The quality system has been assessed, approved ‘and is subject to continuous surveillance according fo Annex Il, Sections 3.3 and 5 of the Directive S9/4Z/EEC ‘The detailed description of the system parts. requirements and measures applied by the manufacturer are presented in the Final Report No. 803601842/2013, which is enclosed to this Certificate Conditions of this Certificate use and related information: 1. It applies only to the quality system maintained in the manufacture of above referenced models of medical ‘devices and it does not substitute the design or type-examination procedures. if requested. 2 The Certificate remains valid until the manufacturing conditions or the quality system are changed but until the 18" March 2018 atthe latest The Certificate validity is conditioned by positive resutts of surveillance audits. 3 4. After fuliting the relevant EU legislation, the manufacturer shall ffx to each medical device, of the above reterenced models, the CE-marking followed by the number of the Notified Body accorting to this example, CE ves RNDr. Radomir Cevelik Issued in Ziin, on 19” March, 2013 125 _/, 4 Representative of the Notified Body No, 1023This is to certify that the Management Systems of i have been assessed by i International Certifications Ltd | and found to comply with the requirements of ISO 9001:2000 Managing Director Certificate Number SAS-ANZ Accreditation bythe Joint Acereditation System of Australia and New Zealand, Ace No. SI400SO4NA. The scope of registration is defined onthe Registration Schedule that accompanies this certificate. | Alkengers Medical Systems Lid, ee |ITC. Certification body of the management system No. 3002 Institute for Testing and Certification, Inc. T, Bati 299, 764 21 Zlin, Czech Republic CERTIFICATE No, 11 0301 SJ We confirm on the bass of a performed aude thal company Allengers Medical Systems Ltd. Head Office: SCO 212-214, Sector 34C, Chandigarh-160022, India Unitt: Bhankharpur, Mubarakpur Road, Derabassi, Distt. Mohali-140507, India Unit2: 1934, HPSIDC Industrial Area, Distt. Solan, HP, India Company Reg. No.: 03551079797 has implemented and documented a functional quality management system in compliance with the requirements of the standard EN ISO 13485:2003 Covering the following activities Design, Manufacture, Installation and Servicing of Medical & Diagnostic Equipments Ine Gemtfcate $ issued on the bass of the resulls mentioned in Audt Report No. 233402688/201 1 The Cerificate validly 1s condoned by positive results of survedlance audits, tina the ceed wompany consid Wo underge Bs Pour bate otissue 04 “7.2017 Vaiewt, 2071 2004 og Pavel Vanek } se of me Frstcen Seaton awarding 2% 10 2005 Head of Contieston Body