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ISO13485 Certificate

ISO13485 Certificate

Product catalog summary
Certificate Holder: Beijing Sano Laser S&T Development Co., Ltd., located at Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District, 101300 Beijing, People's Republic of China.
Facility: Same as the certificate holder's address.
Scope of Certificate: The certificate covers the design, development, production, and sales of various medical devices including Diode Laser Hair Removal Systems, Q-switched Nd: YAG lasers, CO2 Laser Therapy Systems, Intense Pulsed Light Therapy Machines, Cryolipolysis Fat Slimming Machines, and Powered Muscle Stimulators (HI-EMT MAGSHAPE) for medical use.
Applied Standards: The quality management system complies with ISO 13485:2016, including amendments EN ISO 13485:2016/AC:2018 and EN ISO 13485:2016/A11:2021, which are standards for medical devices quality management systems for regulatory purposes.
Certification Body: TÜV SÜD Product Service GmbH, Munich, Germany.
Certificate Validity: The certificate is valid from May 13, 2025, to May 12, 2028.
Additional Information: The certificate confirms that the company maintains a quality management system meeting the specified standards and all applicable requirements of the TÜV SÜD Group's Testing, Certification, Validation, and Verification Regulations.
Report Number: BJ25011501
Certification Authority: Christoph Dicks, Head of Certification/Notified Body.
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Catalog excerpts

ISO13485 Certificate-1

Certificate No. Q5 004064 0003 Rev. 01 Holder of Certificate: Beijing Sano Laser S&T Development Co.,Ltd. Room 7-201,No.1,Caida 3rd Street,Nancai Town Shunyi District 101300 Beijing PEOPLE'S REPUBLIC OF CHINA Beijing Sano Laser S&T Development Co.,Ltd. Room 7-201,No.1,Caida 3rd Street,Nancai Town, Shunyi District, 101300 Beijing, PEOPLE'S REPUBLIC OF CHINA See Scope of Certificate Certification Mark: Design and Development, Production and Sales of Diode Applied Standard(s): ISO 13485:2016 (EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021) Medical devices - Quality management systems Requirements for regulatory purposes Laser Hair Removal System, Q-switched Nd: YAG laser, CO2 Laser Therapy Systems, Intense Pulsed Light Therapy Machine, Cryolipolysis Fat Slimming Machine, Powered Muscle Stimulator(HI-EMT MAGSHAPE)for Medical Use. 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, Certification, Validation and Verification Regulations TÜV SÜD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:Q5 004064 0003 Rev. 01 Report No.: Valid from: Valid until: Christoph Dicks Head of Certification/Notified Body Page 1 of 1 TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Mu

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