Quality systems, regulation and certificates
Every device supplied by SURGIPRO is supported by internationally recognized quality standards, comprehensive regulatory compliance, and complete product registration documentation. We're committed to quality, safety, and reliability, so healthcare professionals get medical devices that meet strict regulatory requirements and deliver consistent clinical performance.
Internationally certified quality systems
TIBTEXNIKA LLC produces interventional cardiology devices using advanced manufacturing technologies that comply with Good Manufacturing Practices. The company operates under internationally certified Quality Management Systems. These strict quality standards apply to every phase of the manufacturing process. This ensures consistent product quality, safety, reliability, and performance in line with international requirements for medical device manufacturing.
ISO 13485:2016
Medical Devices — Quality Management Systems. The internationally recognised QMS standard specifically for the design, development and manufacture of medical devices.
ISO 9001:2015
Quality Management Systems — the general international QMS standard, applied across the manufacturer's operations for continuous improvement.
Production Licence
Licence for the production of medical devices, issued in February 2020 — TIBTEXNIKA operates as a licensed medical-device manufacturer.
CE Certificate (EU MDR)
TIBTEXNIKA devices are covered by a CE registration under EU MDR 2017/745, with Khang Bao International (Hungary) acting as European Authorised Representative — conformity for cardiovascular systems and devices, Class I, II and III.
Certificates
TIBTEXNIKA LLC maintains an internationally recognized Quality Management System (QMS) Certificate, Good Manufacturing Practice (GMP) Certification, a valid Production Licence and Additional Regulatory Certifications & Approvals. These certifications reflect TIBTEXNIKA LLC's ongoing commitment to excellence in manufacturing, quality assurance, patient safety, and continuous improvement across its entire product portfolio.Click any certificate below to view the full-size document and verification details.
ISO 13485:2016
Medical Devices — Quality Management System
IGIC · Cert. 22-B-1466
ISO 9001:2015
Quality Management System
ASTRAIA · Cert. QMS-4673-2020
Production Licence
Licence for the production of medical devices
Republic of Uzbekistan · Licence № 15536
CE Certificate
EU MDR 2017/745 — European Authorised Representative
KB International · Reg. EAR/7197
Registration certificates
TIBTEXNIKA LLC is duly registered with the relevant Ministry of Health and applicable regulatory authorities, operating in full compliance with established medical device regulations and industry standards.
SINOTECH+ Sirolimus DES
Cert ref: TB/M 00507/10/21
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SINOTECH+ Everolimus DES
Cert ref: TB/M 00508/10/21
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