
MDSAP | MEDICAL DEVICE SINGLE AUDIT PROGRAM | Certification Mark: 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 Design and Development, Production, Distribution, and Servicing of Diode Laser Hair Removal System for Medical Use, Dermal Cooling System (Cryojet Plus), Powered Muscle Stimulator (Hi-Emt Magshape), CO2 Laser Therapy Systems, picosecond Nd: YAG Laser, Radio Frequency System, Cryolipolysis Fat Slimming Machine Regulatory Authority(ies): Australia TGA, Brazil ANVISA, Health Canada, Japan MHLW / PMDA, USA FDA. See attached for listing of specific regulatory requirements. The Certification Body of TUV SUD 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. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:QS6 004064 0005 Rev. 00 TUV SUD America Inc. is an MDSAP Recognized Auditing Organization. REPs Facility ID: Report No.: Effective Date: Expiry Date: TUV SUD America, Inc. • 401 Edgewater Place Suite #500 • Wakefield • MA 01880 • USA • www.tuvsud.com
Open the catalog to page 1ZERTIFIKAT ♦ CERTIFICATE ♦ iSltlf* ♦ CEPTMcDMKAT ♦ CERTIFICADO ♦ CERTIFICAT MDSAP | MEDICAL DEVICE SINGLE AUDIT PROGRAM | Regulatory Requirements: Audit/Certification CriteriaAustralia Therapeutic Goods (Medical Devices) Regulations 2002 - Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance Procedure Brazil - RDC ANVISA n. 665/2022 - Good Manufacturing Practices Canada - Medical Device Regulations - Part 1- SOR 98/282 - MHLW Ministerial Ordinance No. 169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) United States - 21 CFR Part 803 Facility(ies): Beijing Sano Laser...
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