ISO 13485
Request the manufacturer’s current quality-system documentation.
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
The manufacturer’s catalog references ISO 13485, CE and FDA-related quality or regulatory standards. Supporting documentation, product-specific regulatory status and Canadian market availability must be confirmed before ordering or use.
CE Information
Confirm whether CE documentation applies to the specific product.
FDA Information
Verify any U.S. registration, listing or clearance for the relevant product.
Canadian Status
Confirm current Canadian licensing, availability and applicable instructions for use.
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