Barreleye Inc. has obtained the Certificate of Good Manufacturing Practice (GMP), confirming full compliance with regulatory standards for medical device manufacturing and quality management.
This certification authorizes Barreleye to manufacture and manage the quality of its AI-driven ultrasound Software as a Medical Device (SaMD) solutions.

Certification Details

• Certification Type: Certificate of GMP (Good Manufacturing Practice)
• Product Category: SaMD (Software as a Medical Device)
• Date of Acquisition: September 1, 2023
• Issuing Authorities:
  – Director, Seoul Regional Ministry of Food and Drug Safety
  – President, Korea Testing Laboratory