Quality management system
ISO 13485:2016
Certified quality management system for applicable medical-device activities.
- Certificate no.
- MI000240
- Valid until
- November 10, 2027
Quality & Certifications
Documentation that supports a qualified distributor review.
Surgi Bio maintains an ISO 13485:2016 quality management system and KGMP certification for applicable medical-device activities and manufacturing operations.
Document accessAvailable during qualified review
Certificates and detailed regulatory documents are provided directly to qualified business partners.
Manufacturing quality system
KGMP
Korean Good Manufacturing Practice certification for the applicable manufacturing facility.
- Recognition no.
- KTL-ABBA-20791
- Valid until
- June 2, 2027
Document package
Information provided according to the stage of review.
Initial contacts receive a concise product overview. Detailed technical, quality, regulatory and commercial documents are shared as the distributor review becomes more specific.
Regulatory status
The product is not currently CE-marked. Product availability, indications and regulatory status vary by market, and local registration feasibility should be reviewed before market entry. This website is not a substitute for current product documentation or local regulatory review.
Qualified business inquiry