International Regulatory Compliance Information

Establishment Registration

FDA

US FDA Good Manufacturing Practice (GMP)
Restech is compliant with 21 CFR Part 820, US FDA Quality Systems Regulations

Notified Body/Registrar/Certification Body

Restech maintains ISO 13485:2003 certification and is audited annually by

Underwriters Laboratories
2600 N.W. Lake Rd.
Camas, WA 98607-8542
877.854.3577
www.ul.com
UL


Quality Management System

ISO 13485: 2003

Product Certifications and Approvals

Australia
> ARTG Certificate

Canada
> Health Canada Medical Device License
> ISO 13485 Certificate
> Medical Device Listing

Europe
> EC Certificate

Taiwan
> TFDA Certificate

Global Regulatory Representatives


Emergo

Europe – Emergo
The Hague, Netherlands
Phone: +31.70.345.8570
www.emergogroup.com/services/europe







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