Regulatory Compliance Information
Quality Management System
- ISO 13485 quality system certification
- US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. FDA Establishment Registration Number: 3007134070
Product Certifications and Approvals
United States
- SerpENT™
- ENTact™ Septal Stapler
- BioElast™ 5-0 Suture
Canada - Medical device licenses
- Heath Canada Clearances are pending
EUROPE - CE Marking certificates
- ENTact™ Septal Stapler
- MediENT™ Middle Turbinate Implant
EUROPE - Declarations of Conformity
- SerpENT™
- ENTact™ Septal Stapler
- MediENT™ Middle Turbinate Implant
Global Regulatory Representatives
Europe - Authorized Representative
Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
Notified Body / Registrar / Certification Body
ENTrigue Surgical, Inc. maintains ISO 13485:2003 certification and is audited periodically as required by:
SGS
Houston, TX USA
Telephone: +1.281.873.5800
http://www.us.sgs.comÂ
ClinicalTrials.gov Registrations
NCT00740480
CSA 2008-01 “A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact™ Septal Staple System for Tissue Approximation During Septoplasties”
NCT00896883
CSA2008-02 “A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum”
NCT00957502
CSA2009-03 “A Prospective, Limited-use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples with Extended Shelf Life”
Biologic Licenses
FDA HCT/P Establishment Registration
- California
- Florida
- New York
- Maryland - pending
