Corporate Regulatory Information
In 2020, Action Products, Inc. received a BSI certification for the ISO 13485:2016 Medical Device and Quality Management Systems (QMS). This certification is an internationally recognized standard that ensures medical products are safe for their intended purpose through the process of consistent design, development, production, and sales. To be certified to this standard, an organization must demonstrate the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
Authorized Representative Contact Information
Within the European Union contact the Authorized Representative
(Regulatory Affairs only):
- Emergo Europe
Westervoortsedijk 60, 6827 AT Arnhem, The Netherlands
Tel: (31) (0) 70 345-8570
Email: EmergoEurope@ul.com
Within the UK contact the UK Responsible Person
(Regulatory affairs only):
- Emergo Consulting (UK) Limited
c\o Cr360 – UL International, Compass House, Vision Park Histon, Cambridge CB24 9BZ, United Kingdom
Tel: +44 ()) 1223 772 671
Email: UKRPvigilance@ul.com
Within Switzerland contact the Swiss Authorized Representative
(Regulatory affairs only):
- MedEnvoy Switzerland
Gotthardstrass 28, 6302 Zug, Switzerland
Email: EmergoVigilance@ul.com - OR Table Replacement Pads, Disposable Covers, and Stool Covers not included
- Excludes DME (Home Medical) and OR items listed above
