ISO 13485
Certified Quality Management System
Certifications & Regulatory Compliance
Committed to Quality and Regulatory Excellence
Quality-system and regulatory information relating to our brand partner and applicable products.
Bioteque Quality & Regulatory Information
Bioteque maintains an ISO 13485-certified quality management system. Applicable products carry CE marking and are registered or listed with the U.S. Food and Drug Administration. Bioteque Vaginal Pessaries have received FDA 510(k) clearance under K013289.
CE Marking
CE-Marked Products
FDA Registration
Registered and Listed Medical Devices
FDA 510(k) Clearance
Bioteque Vaginal Pessaries - K013289
Documentation Requests
Contact Beauray Inc. to request current supporting documentation for a specific product. Certification, registration or clearance status should be confirmed for the relevant product and market before purchase or use.
Request Documentation