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QUALITY ASSURANCE

Novoxel™ is committed to Quality and to consistently maintain the level of operations required to meet customer requirements.
Novoxel™ is certified and operates a Quality Management system which complies with the requirements of ISO 13485:2016 for design
manufacture and customer support of thermo- mechanical ablation systems in dermatology.
Regulation
Novoxel™ is regulated and certified under EC Certificate- CE643960, Full Quality Assurance System Directive 93/42/EEC on medical
Devices, Annex II excluding section 4.
Novoxel™ family of products comply with additional local regulations in the countries where they are marketed.
Certificates
• ISO 13485:2016 for design manufacture and customer support of thermo- mechanical ablation systems in dermatology.
• EC Certificate according to the medical Device directive
• Australia: Therapeutic Goods (medical Devices) Regulations, 2002, Schedule 3 Part 1(excluding Part 1.6) – Full Quality Assurance
Procedure

PATENTS

Novoxel Ltd.’s Issued Patents and Designs Prosecuted by Korakh & Co.
KORAKH & Co. REF. TERRITORY PATENT NUMBER TITLE
005396US USA US 9,402,678 B2 TITLE METHODS AND DEVICES FOR TISSUE ABLATION
005396USD USA US 10,327,832 B2 METHODS AND DEVICES FOR TISSUE ABLATION
005396EP European Union EP 2 459 092 B1 DEVICE FOR TISSUE VAPORIZATION
005396IL Israel 217734 METHODS AND DEVICES FOR TISSUE ABLATION
005396JP Japan P5774001 METHODS AND DEVICES FOR TISSUE ABLATION
005397CN China ZL 2014 8 0074496.5 DEVICES AND METHODS FOR TISSUE VAPORIZATION
005399CN China ZL 2015 8 0061055.6 METHODS AND DEVICES FOR THERMAL TISSUE VAPORIZATION AND COMPRESSION