Quality Certifications & Accreditations
Registrations
- FDA Registration — Owner Operator Number: 10087434
- FDA Registration — Establishment Registration Number: 3030691709
- FDA Registration Scope:
- Medical Device Processing (CDRH)
- Human Tissue Processing (CBER)
- USDA APHIS Registration — Reference Numer: SD-PF0-0005-EU-2024
Quality Without Compromise
All of our processes meet the highest-grade industry benchmarks for quality, designed from the ground up to adhere to ISO 13485, ISO 11137, and ISO 9001 standards for medical device manufacturing, radiation sterilization, and quality management systems.
