bsi. Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 By Royal Charter This is to certify that: ‘Trivitron Healthcare Pvt. Ltd. Plot No. A2 & A3, SIPCOT Industrial Park Irungattukottai, Sriperumbudur Taluk * \ Kancheepuram District 602105 \ Tamil Nadu India Holds Certificate No: MD 712008 and operates a Quality Management System which complies with the requirements of ISO 13485:2016 fot the following scope: 28 JL 207 ‘The Design, Development, Manufacture and Distribution of In Vitro Diagnostics Devices such as Rapid Test (POCT) Kits, ELISA Test Kits, Blochemicy and Haematology Reagents and Molecular Biology Diagnostics Kits. x For and on behalf of BSI: Stéwart Brain, Head of Compliance & Risk - Medical Devices Original Registration Date: 2019-12-18 Effective Date: 2019-12-18 Latest Revision Date: 2019-12-18 Expiry Date: 2022-12-17 ‘Spy of this documenticeriiicate has been kept on record with the chamber, Page: 1 of 1 making excellence a habit”CHONG NHAN HOP PHAP HOA LANA sy CONSULAR AUTHENTICATION aude gi entbsi. Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 9001:2015 By Royal Charte! This is to certify that: Trivitron Healthcare Pvt. Ltd, Plot No. A2 & A3, SIPCOT Industrial Park Irungattukottai, Sriperumbudur Taluk Kancheepuram District 602 105 Tamil Nadu India Holds Certificate No: FM 712007 ‘and operates a Quality Management System which complies with the requirements of ISO 9001:2015 for the following scope: ‘The Design, Development, Manufacture and Distribution of In Vitro Diagnostics Devices such as Rapid Test (POCT) Kits, ELISA Test Kits, ee and Haematology Reagents and Molecular Biology Diagnostics Kits. UA T ve a ED f A copy ofthis documenticerifcate « woFARY PUBLIC fas beanie onc te camber For and on behalf of BSI: Chris Cheung, Head of Compliance & Risk - Asia Pacific Original Registration Date: 2019-12-18 Effective Date: 2019-12-18 Latest Revision Date: 2019-12-18, Expiry Date: 2022-12-17 Page: 1 of 1(CHONG NHAN/ HOP PHAP HOA LANH sy comuararen 1 men oo Sameer 2.40 Ong (Ba). SUNIL CHANAP Cay Saree ata __ feng 22 7, 2 7. nnn agin VB Nan An D6 08h 0166.20/21480H1 0139 Altar: Wis ied Fr cen 3 ea eee A feted dor no respane docuniai retin NES" fen oa Ministy of Exton:2! A055 scomghe oe et " ro cee / AT i SoRRN Depeion a et ements ste oeCERTIFICATE This is to Certify that the Management System of Trivitron Healthcare P' * CERTIFIC. SITE 1-:AMTZ Campus, Pragati Maidan, Vishakhapatanam- 530031, India SITE 2-:Plot No. A2 and A3, Sipcot Industrial Park, Thandalam Village, Sriperambudur Post, Sriperumbudur Taluk, Kanchipuram Dist Chennai-602106, Tamilnadu, India has been found to conform to the Medical Devices - Quality Management System standard: ISO 13485:2016 The Certificate is Vaild for the following scope of operations: MANUFACTURER AND SUPPLIER OF ULTRASOUND SCANNER, ULTRASOUND SCANNER PROBE,PATIENT MONITOR, VENTILATOR, INFUSION PUMP, SYRINGE PUMP, ECG MACHINE, DIALYSIS MACHINE, DIALYSER, DEFIBRILLATOR, ANESTHESIA MACHINE, SUCTION MACHINE, HOSPITAL FURNITURE (OT TABLE, OT PENDANTS, OT LIGHT), AUTOCLAVE, PROTECTIVE COVERALLS, FACE MASK, HAND GLOVES, HAND SANITIZER , DISINFECTANTS, IVD KITS, IVD INSTRUMENTS AND REAGENTS FOR BIOCHEMISTRY, HEMATOLOGY, IMMUNOLOGY, MOLECULAR BIOLOGY, GENOMICS, LCMS, MICROBIOLOGY, COAGULATION, ELECTROLYTE, HPLC, PROTEIN ESTIMATION, IFA, INFECTIOUS RAPID CLIA & ELISA TEST KITS OF HIV, HBV, HCV, MALARIA, DENGUE, SYPHILIS, COVID, INFLUENZA A/B, CARDIAC MARKERS, CANCER MARKERS, THYROID PANEL, TORCH PANEL, HORMONE KITS, CONTROLS, CALIBRATORS, BUFFERS, DETERGENTS AND WASH SOLUTION. CERTIFICADO * CEPTUDUKAT zs INS4017H ificate Ne ¢ ificate Date of initial registration Date of this Certificate Surv. audit on or before/Certificate expiry Recertification Due 19 Feb 2021 19 Feb 2021 18 Feb 2022 18 Feb 2024 ry surveillance audits ‘A copy of this document/certiicate has been kept on record with the chamber, ¢ CERTIFICATE ey Emmanuel ADEMOSU Reno cae CR HMBER OF COMMERCE Director -.Date 2 8 JUL 202t This Cerfeate sre prope of Stuer Managemest & System Service Lin mimedistey nen serancea STAUNCHLY MANAGEMENT AND SYSTEM SERVICES LIMITED abrynth Business Cente, 43 Nicgie Hil Gate. Stockport. Great Manchester, Engin phone = +44 740 482 36 Company Registered in England and Wales with Company Number 11488683 pavaal alaea amy 28 JUL 20% 28 IL 2021 fake nen, insey ot etre 290, Saw OY