Regulatory Compliance Information
Formed in 1998 (originally as iMetrikus), Numera is a healthcare technology company with principal offices in Sunnyvale, California.Numera specializes in interactive health management and remote patient monitoring for populations with conditions that include asthma, diabetes, COPD, cardiovascular disease, obesity as well as general wellness. We market in the United States and internationally through payers, integrated delivery networks, and pharmacies.Numera has developed a Quality Management System to meet and exceed the standards and regulations of the U.S., Canada and European Union. All registrations, certifications and licenses are maintained to ensure that current U.S. and international standards are satisfied. In the U.S., we are in compliance with FDA Regulation, 21 CFR Part 820, Quality System Regulations.
Quality Management System
- ISO 13485:2003 Certificate PDF
- State of California Department of Public Health, Food & Drug Branch Device Manufacturing License PDF
- FDA Registration (search for #2032583)
- Health Canada Medical Device Establishment License PDF
Product Clearances and Certifications
- FDA 510(k) Numera|NET (search for #K091021)
Declaration of Conformity
- MetrikLink® (Numera|NET PDF)
12110 Sunset Hills Road
Suite 200
Reston, VA 20190 USA
Phone: 1.800.862.4977
Fax: 1.703.437.9001
Website: www.bsiamerica.com
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299
Website: www.emergogroup.com


