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ZERTIFIKAT CERTIFICATE E CЕРТИ И кАT CERTIFICADO CERTIFICAT Sustainability & MDSAP Certifications CERTIFICATE The Certification Body of TÜV SÜD South Asia Private Limited certifies that TUV South Asia POLYMED REDITAL DEVICES Poly Medicure Limited Plot No. PA 010-018, PA 010-019, Mahindra world city (Jaipur) Ltd., Multi product SEZ Jaipur - 302 037, Rajasthan, India has implemented Environmental Management System in accordance with ISO 14001:2015 for the scope of Manufacture, Warehouse, Sales and Marketing of Sterile / Non-Sterile Medical Devices for Infusion, Transfusion, General Surgery, Anaesthesia, Gastroenterology, Respiratory, Diagnostics and Cardiogram by Injection Moulding, Plastic Extrusion, Assembly, Packing and Sterilization The certificate is valid from 2022-06-29 until 2025-06-28 Subject to successful completion of annual periodic audits The present status of this certificate can be obtained through TUV SUD website by scanning below QR code and by entering the certificate number (without spaces) on web page. Further clarifications regarding the status & scope of this certificate may be obtained by consulting the certification body at [email protected] Certificate Registration No. 99 104 01414 Date of Initial certification: 2022-06-29 Issue Date: 2022-06-29 Rev. 00 Breake Rahul Kale Head of Certification Body of TÜV SÜD South Asia Private Limited, Mumbai TUV SUD IAF Member of TÜV SÜD Group NABCB EM009 TÜV SÜD South Asia Pvt. Ltd. ⚫ TÜV SÜD House Saki Naka Andheri (East) Mumbai-400072 Maharashtra India www.polymedicure.com TUV ZERTIFIKAT CERTIFICATE E ECEPTиикАт сERTIFICADO CERTIFICAT ISO-14001 CERTIFICATE The Certification Body of TÜV SÜD South Asia Private Limited certifies that POLYMED MEDICAL DEVICES Poly Medicure Limited TUV South As Plot No-34, Sector-68, IMT, Faridabad - 121 004, Haryana, India has implemented Environmental Management System in accordance with ISO 14001:2015 for the scope of Design & Development, Manufacture, Sales and Distribution of Sterile & Non-Sterile Non-Active Non-Implantable Medical Devices for Infusion, Transfusion, General Surgery, Dialysis, Urology, Anaesthesia, Gastroenterology, Cardiovascular, Invitro Diagnostic Respiratory by Injection Moulding, Plastic Extrusion, Assembly, packing and sterilization. The certificate is valid from 2022-06-29 until 2025-06-28 Subject to successful completion of annual periodic audits The present status of this certificate can be obtained through TUV SUD website by scanning below QR code and by entering the certificate number (without spaces) on web page. Further clarifications regarding the status & scope of this certificate may be obtained by consulting the certification body at [email protected] Certificate Registration No. 99 104 01415 Date of Initial certification: 2022-06-29 Issue Date: 2022-06-29 Rev. 00 Reveale Rahul Kale Head of Certification Body of TÜV SÜD South Asia Private Limited, Mumbai Member of TÜV SÜD Group TUV IAF NABCB EM009 ZERTIFIKAT CERTIFICATE СЕРТиикАT CERTIFICADO CERTIFICAT MDSAP MEDICAL DEVICE SINGLE AUDIT PROGRAM CERTIFICATE No. QS6 105485 0009 Rev. 00 Certificate Holder: Certification Mark: Scope of Certificate: Standard(s): Regulatory Authority(ies): POLY MEDICURE LIMITED Plot No. 34 Sector-68, IMT Faridabad, Haryana 121004 INDIA Q TÜV SUD TUV SUD America Manufacture of IV Catheters (Cannula) with/without Safety Features, Infusion Sets, Prefilled Syringe with Saline Solutions, Vial Access Spike, Needle Free Connectors, Auto Disable Syringes, Safety Huber Needle, Spinal Needle, Endotracheal Tubes, Disinfecting Port Protectors, Fistula Needle with/without Safety Features, Blood Line Sets, Dialysis Filters for the areas of Infusion, Anesthesia and Dialysis ISO 13485:2016 Brazil ANVISA, Health Canada, USA FDA. See attached for listing of specific regulatory requirements. The Certification Body of TÜV SÜD America Inc. certifies that the quality management system of the manufacturer listed above has been audited against the stated criteria and found to conform to those criteria for the scope of certification listed. Validity of this certificate can be obtained by visiting the website www.tuvsud.com/ps-cert TÜV SÜD America Inc. is an MDSAP Recognized Auditing Organization. REPS Facility ID: Effective Date: Expiry Date: Page 1 of 2 Date of Issue: 2022-06-28 F005858 2022-06-16 2025-06-15 жи (Renee Walker) Manager, US Certification Body. Medical and Health Services TÜV SÜD America, Inc. 401 Edgewater Place Suite #500 - Wakefield MA 01880 - USA - www.tuvsud.com TUV TÜV SÜD South Asia Pvt Ltd. ⚫TÜV SÜD House Saki Naka ⚫Andheri (East) Mumbai-400072 Maharashtra India TUV ZERTIFIKAT CERTIFICATE ♦ ♦сЕРТИикAT CERTIFICADO CERTIFICAT MDSAP MDSAP MEDICAL DEVICE SINGLE AUDIT PROGRAM POLYMED MEDICAL DEVICES We Care As We Cure CERTIFICATE No. QS6 105735 0007 Rev. 00 Certificate Holder: Poly Medicure Limited Certification Mark: Plot No.PA-010-018, PA-010-019 Mahindra World City (Jaipur) Ltd, Multi-Product SEZ Jaipur, Rajasthan 302037 INDIA TÜV SUD Scope of Certificate: Standard(s): Regulatory Authority(ies): Manufacture of IV Catheters (Cannula) with/without Safety Features, Infusion Sets, Safety Hypodermic Needles, Safety Winged Infusion Set, Blood Transfusion Set, Blood Collection Needle with/without Safety Feature, Blood Collection Tubes, Suction Catheters, Infant Feeding Tubes, High Pressure Vacuum Drainage Bottle, Yankaur Suction Set (Suction Tube and / or Handle), ECG Electrodes and Alcohol Swabs for the areas of Infusion, Transfusion, Diagnostics, Anesthesia, Gastroenterology, General Surgery, Heartbeat Monitoring and Disinfecting ISO 13485:2016 Brazil ANVISA, Health Canada, USA FDA. See attached for listing of specific regulatory requirements. The Certification Body of TÜV SÜD America Inc. certifies that the quality management system of the manufacturer listed above has been audited against the stated criteria and found to conform those criteria for the scope of certification listed. Validity of this certificate can be obtained by visiting the website www.tuvsud.com/ps-cert TÜV SÜD America Inc. is an MDSAP Recognized Auditing Organization. REPS Facility ID: Effective Date: Expiry Date: F005860 2022-07-26 2025-07-25 Page 1 of 2 Date of Issue: 2022-08-09 (Renee Walker) Manager, US Certification Body, Medical and Health Services TÜV SÜD America, Inc. 401 Edgewater Place Suite #500 ⚫ Wakefield MA 01880 USA⚫www.tuvsud.com TUV Confidential | Slide 18 TUV SUD America

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