Regulatory

International Regulatory Compliance Information

 

This page shows a short summary of NightBalance’s international regulatory compliance information. Related documents, declarations and certificates are available upon request.

 

QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system (not certified yet)

 

PRODUCT CERTIFICATIONS AND APPROVALS
Europe – CE certified
• Sleep Position Trainer (model ‘Pyxis’)
• Pose (model ‘Pyxis’)

 

Australia – ARTG listed
• Sleep Position Trainer (model ‘Pyxis’)

 

Canada – MDEL (via distributor)
• Sleep Position Trainer (model ‘Pyxis’)

 

GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs, issues and incident reporting:

 

Australia – Sponsor Representative
Emergo Australia, Sydney, Australia
Telephone: +61.2.9006.1662
Emergo Australia!