Hangzhou, China - September 2026 - Surgiclean®, the hemostatic medical device brand of Hangzhou Singclean Medical Products Co., Ltd., has reached another important milestone in its international regulatory development. The company's Absorbable Hemostatic Gauze, based on oxidized regenerated cellulose (ORC), has obtained EU MDR certification under Certificate No. MDR.2292-2026/0023.
The certification represents an important step in Surgiclean's continued expansion of its international absorbable hemostat portfolio and provides additional regulatory support for medical device distributors, surgical institutions and OEM/ODM partners evaluating advanced hemostatic solutions.
EU MDR Certification Strengthens Surgiclean's International Market Position
The European Union Medical Device Regulation (EU MDR) establishes stringent requirements for the safety, performance and regulatory compliance of medical devices entering the European market. For manufacturers of absorbable hemostatic products, achieving MDR certification represents a significant regulatory milestone and demonstrates the importance of robust quality management, product evaluation and technical documentation.
With the new certification, Surgiclean® Absorbable Hemostatic Gauze further strengthens its international regulatory profile and provides distributors with an additional compliant product option for their surgical hemostasis portfolios.
The certification number is MDR.2292-2026/0023.
For global medical device distributors, regulatory readiness is increasingly becoming an important consideration when selecting an absorbable hemostat manufacturer. In addition to product performance and commercial competitiveness, distributors need suppliers capable of supporting market registration, technical documentation, product training and long-term supply.
Surgiclean's continued investment in international regulatory compliance is designed to address these requirements.
Advanced ORC Technology for Absorbable Hemostasis
Surgiclean® Absorbable Hemostatic Gauze is manufactured using oxidized regenerated cellulose, a plant-derived material designed to provide absorbable hemostatic support during surgery.
According to the product technology presented by Surgiclean, the product combines 100% plant-origin material, controlled oxidation and specialized formation technology. The controlled oxidation process is designed to provide consistent material characteristics, while the product's soft and flexible structure allows it to be adapted to different surgical sites.
The product is designed as an adjunctive hemostatic device for controlling bleeding when conventional surgical techniques such as ligation or cauterization may be difficult to apply or insufficient.
Its absorbable design also provides an important operational advantage in surgery. After achieving hemostasis, appropriate excess material can be removed according to the product's instructions for use, while the remaining material is gradually degraded and absorbed.
Surgiclean's current product information specifies that the ORC absorbable hemostatic gauze can achieve hemostasis within approximately 3 minutes and can be fully degraded and absorbed within 28 days, subject to the applicable product instructions and clinical conditions.
Evidence-Based Product Development
Surgiclean's product development strategy places emphasis on both material science and performance evaluation.
The company's product materials include experimental evaluations of hemostatic performance, including animal models assessing hemostasis following tail amputation in mice and liver incision models in New Zealand rabbits. The supplied product presentation also includes comparisons of clinical efficiency and hemostasis time between experimental and control groups.
These evaluations form part of Surgiclean's broader approach to developing absorbable hemostatic materials based on controlled manufacturing processes and performance assessment.
The product's ORC technology is also designed around several complementary mechanisms of hemostasis. Upon contact with blood, the material can absorb blood, swell and form a gelatinous matrix at the bleeding site. This provides localized physical coverage while the material's chemical characteristics support the hemostatic process.
For surgical teams and medical device distributors, this combination of absorbability, flexible handling and rapid hemostatic support makes ORC gauze an important category within modern surgical hemostasis.
Surgiclean Absorbable Hemostatic Dressing
Designed for Diverse Surgical Applications
Surgiclean® Absorbable Hemostatic Gauze is intended to support bleeding control across a broad range of surgical procedures.
The product can be used in applications including:
General surgery
Abdominal surgery
Breast surgery
Hernia surgery
Gastric surgery
Hepatobiliary surgery
Gynecological surgery
Thyroid surgery
ENT procedures
Management of superficial surgical bleeding
The gauze is available in multiple dimensions and can be cut or shaped according to the surgical site and bleeding area, providing flexibility for different procedural requirements.
As with all medical devices, application should follow the approved indications, contraindications and instructions for use applicable to the specific market and product registration.
A Strategic Opportunity for Global Hemostatic Product Distributors
The latest MDR certification also creates additional opportunities for distributors seeking to expand their portfolios of absorbable hemostatic gauze, hemostatic gauze dressing, absorbable hemostat and surgical hemostatic products.
For distributors, working with a manufacturer involves more than sourcing an individual product. Reliable regulatory documentation, manufacturing consistency, product specifications, technical support and long-term supply capacity can all influence the success of a medical device portfolio.
Surgiclean is supported by the manufacturing and R&D capabilities of Hangzhou Singclean Medical Products Co., Ltd. The company reports that it has established international sales channels across more than 120 countries and regions, works with more than 330 global OEM/ODM/OBL partners and invests more than 10% of revenue in R&D each year.
These capabilities enable Surgiclean to support different cooperation models, including distributor partnerships, OEM/ODM projects, regulatory documentation support and customized product requirements.
For medical device distributors looking to introduce ORC hemostatic gauze or broaden an existing surgical hemostasis portfolio, Surgiclean's combination of product technology, manufacturing capability and international regulatory experience provides a foundation for long-term cooperation.
Continuing the Development of a Global Hemostasis Brand
The EU MDR certification of Surgiclean® Absorbable Hemostatic Gauze is more than a regulatory milestone. It represents another step in the development of Surgiclean as an international brand specializing in surgical hemostatic solutions.
Building on its experience in absorbable biomaterials, Surgiclean continues to develop a portfolio covering absorbable hemostatic gauze, hemostatic powders, hemostatic particles, collagen hemostatic sponges and other surgical hemostatic solutions.
With increasing demand for efficient, absorbable and easy-to-handle hemostatic products, Surgiclean will continue investing in product development, quality management and international regulatory compliance to support healthcare professionals and medical device partners worldwide.
Certificate No.: MDR.2292-2026/0023
Product: Surgiclean® Absorbable Hemostatic Gauze
Material: Oxidized Regenerated Cellulose (ORC)
Application: Adjunctive surgical hemostasis
Cooperation: Global distributors, medical device importers, hospitals and OEM/ODM partners
For distributors interested in Surgiclean® Absorbable Hemostatic Gauze, product samples, regulatory documentation, distributor pricing, OEM/ODM cooperation or market registration support, please contact the Surgiclean team.