regulatory

certifications, registrations & licenses

To provide efficient information transfer to customers and distribution partners, BioHorizons provides this "Regulatory & Quality" page for interested parties to access frequently-requested documents that confirm BioHorizons certifications, registrations and licenses. Links to related websites are also provided to access additional regulatory related information.

Health Canada CTO Registration Certificate

UK HTA License

California Tissue Bank License

Certificate of Registration; Quality Management System-ISO 13485:2016 & EN ISO 13485:2016

Delaware Tissue Bank Registration

EC Certificate - Full Quality Assurance System, Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

FDA Establishment Registration and Listing for HCT /Ps

Florida Tissue Bank

Maryland Tissue Bank Permit

New York Tissue Bank License

Oregon Tissue Bank Registration

MDSAP Certificate of Registration - Quality Management System - ISO 13485:2016

regulatory bodies

U.S. FDA | medical devices

Health Canada | medical devices active licence listing

UK Human Tissue Authority | licensing and inspections

Australia Therapeutic Goods Administration | australian register of therapeutic goods

product partners

LifeCell Corporation | regulatory licensing documentation

certifications, registrations & licenses

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