Regulatory Compliance
BioMers Products is compliant to all regulatory requirements as set out by the U.S. FDA, Health Canada, European Medical Device Directive, Australia's TGA and Japan's PMDA. All certificates and approvals pertaining to regulatory compliance are listed below.
QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification (PDF format)
U.S. FDA Good Manufacturing Practice (GMP)
The company is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
Product Certifications and Approvals
AUSTRALIA - Devices listed in ARTG (Links to TGA website)
ASTICS® Retainer | Translucent Arch Wire |
CANADA- Medical device licenses (PDF format)
ASTICS® Retainer | Translucent Arch Wire |
EUROPE - CE Marking certificates (PDF format)
ASTICS® Retainer | Translucent Arch Wire |
EUROPE - Declarations of Conformity (PDF format)
ASTICS® Retainer | Translucent Arch Wire (Short Duration) | Translucent Arch Wire |
UNITED STATES - FDA 510(k) approval and/or FDA registration (Links to US FDA database device listing)
ASTICS® Retainer | Translucent Arch Wire |
Global Regulatory Representative
Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here.
AUSTRALIA - Sponsor Representative
Emergo Australia Pty. Ltd., Sydney, AUSTRALIA
Tel: +61 2 9006 1662
Website: http://www.EmergoGroup.com
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Tel: +31 70 345 8570
Website: http://www.EmergoGroup.com
Notified Body / Registrar / Certification Body
The company maintains ISO 13485:2003 certification and is audited every year by:
SGS U.S. Testing Company Inc.
515 West Greens Road, Suite 775
Houston, TX, 77067
Tel: (281) 873-5800
Fax: (281) 873-5858
Website: www.us.sgs.com
Material Safety Data Sheets
