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TUV certificate -KDL Medical- Q5 036336 0056 Rev. 02

TUV certificate -KDL Medical- Q5 036336 0056 Rev. 02
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TUV certificate -KDL Medical- Q5 036336 0056 Rev. 02 - 1

Certificate No. Q5 036336 0056 Rev. 02 Holder of Certificate: Zhejiang Kindly Medical Devices Co., Ltd. No.758, 5th Binhai Road Binhai Industrial Park, Longwan District 325025 Wenzhou, Zhejiang Province PEOPLE'S REPUBLIC OF CHINA Certification Mark: Design, Development, Production, Sales and Distribution of Disposable Needles, Scalp Vein Sets, Syringes, Infusion Sets, Transfusion Sets, Burette-Type Infusion Sets, Blood-Collecting Needles, Dental Needles, Anaesthesia Needles, Stopcock, Heparin Cap/Stopper, Extension Sets, Huber Needles, Fistula Needles, Dental Operation Instruments (Odontotenaculum, Odontoscope), Disposable Vacuum Venous Blood Specimen Collection Containers (tube), Sterile Infusion Sets for Single Use, Sterile Dual-purposed Connector for Single Use, Sterile Injection Site for Single Use, Sterile Drip Chamber for Single Use, Sterile Piercing Device for Single Use, Sterile Syringes for Single Use, Sterile Irrigation Needles for Single Use, Sterile I.V. catheter for single use, Disposable Insulin Pen Needle, Sterile Intravascular Catheter Introducer for Single Use, Sterile Biopsy Needles for Single Use, Sterile Percutaneous Vertebroplasty Kit for Single Use, Sterile Dispensing Needles for Single Use, Safety Needles, Safety Scalp Vein Sets, Safety BloodCollecting Needles, Safety I.V. Catheter for Single Use, Safety Fistula Needles, Luer Adapter, Safety Blood Lancet, Blood Collection Assembly, Irrigation Syringes, Sterile Syringes for Insulin for Single Use, Sterile Disinfecting Cap for Single Use, Blood Collection Sampling Holder. The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system, which meets the requirements of the listed standard(s). All applicable requirements of the testing and certification regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:Q5 036336 0056 Rev. 02 Report No.: Valid from: Valid until: Christoph Dicks Head of Certification/Notified Body Page 1 of 2 TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich

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TUV certificate -KDL Medical- Q5 036336 0056 Rev. 02 - 2

Certificate No. Q5 036336 0056 Rev. 02 Applied Standard(s): EN ISO 13485:2016 Medical devices - Quality management systems Requirements for regulatory purposes (ISO 13485:2016) DIN EN ISO 13485:2016 Zhejiang Kindly Medical Devices Co., Ltd. No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District, 325025 Wenzhou, Zhejiang Province, PEOPLE'S REPUBLIC OF CHINA Page 2 of 2 TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich •

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