ISO 13485:2016 Certified: 

• Certificate Number: #HK18/42003.01

• Continuous Excellence: Maintained since 2017 with an unbroken audit track record.

• Scope: Procurement, supply chain management, and quality control of medical devices and resuscitators.

Regulatory Alignment: 

• US FDA (21 CFR Part 820 / QSR): Registration Number:3014507910    Audit-verified quality system compliance and Device Master Record (DMR) maintenance.

• EU CE MDR: Complete technical documentation support, clinical evaluation, and CE compliance.

• UDI: Full barcode and batch labeling compliance for global traceability.