Compliance Centre
Regulatory documentation
MDR Article 11
EU Authorised Representative
As a non-EU manufacturer, Links Medical Products, Inc. has appointed an EU Authorised Representative in accordance with Article 11 of the EU Medical Device Regulation (EU) 2017/745. The EU REP acts as our point of contact for competent authorities and may be contacted on any regulatory matter relating to the Silent Knight in the European Union.
EU Authorised Representative
Cost Saving Solutions Europe Ltd
- Unit 35 Centre Block, Docklands Innovation Park, East Wall Road, D03 E086, Dublin, Ireland
- Single Registration Number (SRN)
- IE-AR-000016085
Legal Manufacturer
Links Medical Products, Inc.
- 15979 N 76th Street, Suite D, Scottsdale, AZ 85260, United States
- Single Registration Number (SRN)
- US-MF-000021290
- +1 949 753 0001
- info@linksmed.com
Need a signed authorisation mandate?
Contact regulatory affairs