Defining the Technology
Behind Life-Saving Rescue
Guangzhou Ruten Medical Technology Co., Ltd., founded in 2011, specializes in high-performance hemostasis product R&D and manufacturing using kaolin, zeolite, and chitosan. We control the full chain from raw material formulation to sterilization packaging — for 15 years, we have done one thing: ensuring every hemostatic dressing saves a life when it matters most.
200+
Partner Hospitals & Institutions
20+
Countries Covered
5+
International Certifications
50+
Team Members
Founding Story
In 2011, Ruten Medical was founded in Guangzhou. The founding team understood the pain points of the hemostasis material industry deeply: international brands charge premium prices with long lead times, while domestic suppliers struggle to meet global market demands for quality consistency and compliance capabilities. Ruten chose the harder but right path — starting from fundamental materials science, controlling the full chain from formulation R&D to sterilization packaging.
Our Mission
Delivering high-performance hemostasis closed-loop solutions to military, pre-hospital, and clinical surgical sectors worldwide. Saving every life at the critical moment through advances in materials science.
Our Vision
Become the global core supplier of hemostasis materials by 2028, advancing FDA 510(k) registration and expanding into North American and European mainstream markets.
Core Capabilities
Four core capabilities driving every aspect of our business, from materials R&D to global supply.
Materials R&D
12-person R&D team with 200+ in vitro coagulation tests and 50+ animal model validations completed. Core formulations and processes across kaolin, zeolite, and chitosan platforms.
Scale Manufacturing
4,000 sqm ISO Class 7 cleanroom facility producing 3.3 million hemostatic dressings annually. Full digital production control supporting million-unit bulk procurement.
Full-Chain Quality Control
Four-stage inspection from raw material receipt to finished product release, 100% batch traceability. 5,000+ annual test batches with mandatory 10-year data retention.
Global Supply
Products exported to 20+ countries across Southeast Asia, Middle East, and Africa. 50+ international OEM brand partnerships. Full DMR, validation reports, and bilingual clinical white paper support.
Certifications & Global Standards
Our
Journey
From our founding in 2011, Ruten Medical has completed the leap from laboratory formulations to global exports through sustained R&D investment.
Company Founded
Launched chitosan hemostasis material R&D project, completing first laboratory-stage material formula screening. Started with a 5-person team focused on fundamental materials science.
First FDA Product Registration
First product successfully passed FDA registration. Officially obtained ISO 13485 quality system certification. 4,000 sqm GMP cleanroom facility went into operation with 3.3 million annual capacity.
Full-Scale Production of Three Technologies
Kaolin, zeolite, and chitosan platforms all achieved full-scale production. R&D team expanded to 12 people, completing 200+ in vitro coagulation tests.
Products Deployed in 20+ Countries
Products successfully deployed in 20+ countries worldwide. OEM clients scaled to 50+ companies. FDA facility registration completed, advancing 510(k) registration.
Global Supply Capability
Ruten Medical products cover 20+ countries and regions across Southeast Asia, Middle East, and Africa, serving 50+ international OEM brand clients. We provide comprehensive global market access support.
Complete Registration Support
DMR, validation reports, bilingual clinical white papers to support market access registration in each country.
Flexible Delivery Models
Standard product fast shipping, OEM custom production, split delivery — adapting to different procurement scales.
Tiered Pricing
Lowest per-unit cost for million-unit bulk procurement. Long-term framework agreements and annual procurement plans available.
Frequently Asked Questions About Ruten Medical
When was Ruten Medical founded?+
Ruten Medical was founded in 2011, headquartered in Guangzhou, China. The company specializes in hemostasis material R&D and manufacturing, having developed into a professional manufacturer spanning kaolin, zeolite, and chitosan platforms.
What certifications does Ruten hold?+
FDA registered (USA), CE certified (EU), ISO 13485 quality management system certified, manufactured under GMP standards. Product performance meets CoTCCC tactical medical committee recommended standards.
What is Ruten's production capacity?+
4,000 sqm ISO Class 7 cleanroom facility with 3.3 million hemostatic dressing annual capacity. Standard products ship within 3-5 business days, OEM custom production in 30-45 days.
Which countries does Ruten export to?+
Products are exported to 20+ countries and regions across Southeast Asia, Middle East, and Africa, serving 50+ international OEM brand clients. Currently advancing FDA 510(k) registration to expand into North American and European markets.
Looking for Hemostasis Product Selection or OEM Pricing?
Provide your application scenario, and the Ruten expert team will deliver a customized quotation and technical support within 24 hours. 50+ international brand OEM partnerships, 100% batch traceability.