FDA Registered Surgical Sutures — International Supplier with US Market Access
FDA registration is a critical credential for surgical suture manufacturers seeking to serve the US market and demonstrate compliance with one of the world's most stringent regulatory frameworks. Desmo Care holds FDA registration for surgical suture products manufactured at our 35,000 m² facility in Istanbul, Turkey. This registration, combined with our ISO 13485:2016 certification and CE marking under EU MDR 2017/745, positions Desmo Care as a multi-certified international manufacturer meeting the regulatory standards of the world's most demanding markets. For international buyers, our FDA registration serves as additional validation of our manufacturing quality and regulatory commitment.
Why Choose Desmo Care for United States & International
FDA registered manufacturing facility — surgical suture products listed with the US FDA as Class II medical devices, demonstrating compliance with US regulatory requirements
Triple certification: FDA registered, CE marked (EU MDR 2017/745), and ISO 13485:2016 certified — meeting the standards of the world's most demanding regulatory markets
Quality system harmonized with FDA 21 CFR Part 820 and ISO 13485:2016 — ensuring consistent manufacturing quality recognized by regulatory authorities worldwide
11 suture product lines covering absorbable and non-absorbable categories with 15 needle configurations — comprehensive portfolio for all surgical specialties
Direct manufacturer pricing from our 35,000 m² facility with 300+ employees and 40+ years of heritage — established credibility for US and international procurement
FDA registration serves as a quality benchmark for international buyers in markets where FDA credentials enhance procurement confidence beyond local regulatory requirements
Regulatory Compliance & Certifications
Desmo Care's surgical suture manufacturing facility is registered with the US Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. Our suture products are listed with the FDA as Class II medical devices. FDA registration involves establishment registration, device listing, compliance with 21 CFR Part 820 (Quality System Regulation), and adherence to FDA's medical device reporting requirements. Our ISO 13485:2016 quality management system is harmonized with FDA QSR requirements. Additionally, our products carry CE marking under EU MDR 2017/745 for European market access. This triple certification — FDA, CE, ISO 13485 — demonstrates our commitment to meeting the highest international regulatory standards for surgical suture manufacturing.
Frequently Asked Questions
What does FDA registered mean for Desmo Care sutures?
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FDA registration means that Desmo Care's manufacturing facility is registered with the US Food and Drug Administration, and our suture products are listed as Class II medical devices. This involves compliance with FDA establishment registration requirements, device listing, and adherence to 21 CFR Part 820 Quality System Regulation. FDA registration is a regulatory requirement for medical devices marketed in the United States.
Can Desmo Care sutures be sold in the United States?
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Our manufacturing facility is FDA registered and our suture products are listed with the FDA. For specific US market entry, surgical sutures may require 510(k) premarket notification depending on the product classification and predicate device pathway. We work with US regulatory consultants and distribution partners to navigate the US market access process for our product lines.
How does FDA registration benefit international buyers?
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For buyers outside the US, our FDA registration serves as additional validation of manufacturing quality. Many international markets and hospital procurement committees consider FDA registration a prestigious quality benchmark alongside CE marking and ISO 13485 certification. It demonstrates that our facility and products meet the standards of one of the world's most rigorous regulatory authorities.
Is Desmo Care's quality system compliant with FDA requirements?
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Yes. Our quality management system is ISO 13485:2016 certified and harmonized with FDA 21 CFR Part 820 (Quality System Regulation). This covers design controls, production and process controls, corrective and preventive actions (CAPA), document controls, and management review — all requirements shared between ISO 13485 and FDA QSR.
What other certifications does Desmo Care hold beyond FDA?
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In addition to FDA registration, Desmo Care holds CE marking under EU MDR 2017/745 for European market access, ISO 13485:2016 quality management certification, SFDA approval for Saudi Arabia, and MOHAP approval for the UAE. This portfolio of certifications enables us to serve 50+ countries with products meeting multiple international regulatory frameworks.
Ready to partner with Desmo Care?
Whether you're a hospital, distributor, or procurement team — we'd love to discuss how Desmo Care can serve your market.