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EU Medical CE MDR Certificate

EU Medical CE MDR Certificate

EU Medical CE MDR Certificate

Product catalog summary
Certificate Overview
TÜV SÜD Product Service GmbH, a Notified Body with identification no. 0123, has issued a Quality Management System Certificate under Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapter I. The certificate number is G15 004064 0006 Rev. 00, valid from October 10, 2025, to October 9, 2030.
Manufacturer and Representative
The manufacturer is Beijing Sano Laser S&T Development Co., Ltd., located in Beijing, China. The authorized representative is Prolinx GmbH, based in Duesseldorf, Germany.
Scope and Evaluation
The quality management system has been positively evaluated according to the specified EU regulation. The certificate covers Class IIb devices, specifically laser surgery instruments intended for diode laser hair removal systems to treat hypertrichosis.
Assessment Details
The assessment includes evaluation of technical documentation for Class IIa and IIb devices on a representative basis. For Class III or Class IIb implantable devices, an additional EU Technical Documentation Assessment Certificate is required before market placement.
Surveillance and Compliance
The certified quality management system is subject to periodic surveillance. Compliance with all applicable TÜV SÜD Group Testing, Certification, Validation, and Verification Regulations is mandatory.
Additional Information
For further details and certificate validity, refer to the TÜV SÜD website using the certificate query: cert:G15 004064 0006 Rev. 00.
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Catalog excerpts

EU Medical CE MDR Certificate-1

Zentralstelle der Lander fur Gesundheitsschutz bei Arzneimitteln und Medizinprodukten % EU Quality Management System Certificate Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapter I 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 SRN Manufacturer - CM-MF-000016342 Prolinx GmbH Brehmstr. 56, 40239 Duesseldorf, GERMANY The quality management system has been evaluated in accordance with Regulation (EU) 2017/745, Annex IX Chapter I with a positive result. Details on devices covered by the quality management system are described on the following page(s). The report referenced below summarises the results of the assessment and includes reference to relevant CS, harmonised standards and test reports. The certified quality management system is subject to periodical surveillance. If class I devices in sterile conditions, with measuring function, or reusable surgical instruments are covered by this certificate, the audit was limited to the respective aspects relating to - establishing, securing, and maintaining sterile conditions, - conformity of the devices with the metrological requirements, - reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use. If class IIa or class IIb devices are covered by this certificate, the quality management system assessment was accompanied by the assessment of technical documentation for devices selected on a representative basis. The periodical surveillance includes further assessment of the technical documentation on the basis of representative samples. If class III or class IIb implantable devices are covered by this certificate, an EU Technical Documentation Assessment Certificate in accordance with Annex IX Chapter II is required before placing them on the market. All applicable requirements of the Testing, Certification, Validation and Verification Regulations TUV SUD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:G15 004064 0006 Rev. 00 Valid until: Christoph Dicks Issue date: 2025-10-10 Head of Certification/Notified TUV SUD Product Service GmbH is Notified Body with identification no. 0123 TUV SUD Product Service GmbH • Certification Body • Ridlerstrafce 65 • 80339 Munich • Germany

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EU Medical CE MDR Certificate-2

Zentralstelle der Lander ^ fur Gesundheitsschutz bei Arzneimitteln und js Medizinprodukten % EU Quality Management System Certificate Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapter I Classification: Device Group: Intended Purpose: Z120110 - LASER SURGERY INSTRUMENTS Diode Laser Hair Removal System is intended to treat hypertrichosis The validity of this certificate -none-depends on conditions and/or is limited to the following: Revision History: Initial issuance TUV SUD Product Service GmbH is Notified Body with identification no. 0123 TUV SUD Product Service GmbH • Certification...

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