Why choose Steadlive？ – Wuhan Sitaili Medical Apparatus Development Co., Ltd

Pioneer in China's Ostomy Care Industry

Founded in 2003, Wuhan Steadlive Medical Devices Development Co., Ltd. is the first Chinese manufacturer to independently develop and mass-produce ostomy pouches. With over two decades of specialized expertise in medical consumables, we have built an integrated, end-to-end capability spanning product R&D, scalable manufacturing, and global technical support. Grounded in regulatory compliance and driven by quality excellence, we provide manufacturing partnerships that customers worldwide can depend on.

Quality First, GMP-Compliant Manufacturing

We operate under strict Good Manufacturing Practice (GMP) guidelines, supported by an in-house quality assurance team and a comprehensive quality management system. From incoming material inspection and in-process quality monitoring to finished product release testing, every step follows documented standardized operating procedures. Backed by established R&D capabilities, standardized production processes, and rigorous quality controls, we bring uncompromising professionalism to every product and every partnership.

Fully Certified for Global Markets

We hold over 70 registered patents, maintain ISO 13485 certification, and our products carry FDA clearance and CE marking—meeting the world’s most stringent regulatory requirements. With a strong presence in China and exports to over 70 countries across Europe, Southeast Asia, the Americas, and Africa, our products are widely recognized for consistent, reliable quality.

Large-Scale Production, Reliable Delivery

With deep expertise in the medical consumables industry, we are built on quality and compliance, focused on on-time delivery, and supported by responsive customer service. Leveraging comprehensive certifications, rigorous quality control, scalable production capacity, and a dedicated after-sales team, we deliver flexible OEM/ODM solutions and dependable supply—eliminating uncertainties from your sourcing process. Committed to integrity and long-term mutual growth, we strive to be the strategic partner that medical institutions and distributors can rely on.

Steadlive Certifications

CE DOC confirms full compliance with EU MDR 2017/745, granting CE marking and legal access to the European market.

ISO13485 — ISO 13485 certification demonstrates our globally recognized quality management system across the entire product lifecycle.

2026FDA — FDA clearance verifies our ostomy bags meet US safety and effectiveness standards for market entry.

201620693679.1--造口袋底盘及造口袋 — Our patents protect our unique innovations in customized ostomy solutions and differentiated care designs.

会员单位 — Our We·BIO membership connects us with Wuhan's leading biomedical innovation network.

201921221317.2--一种用于造口袋异味过滤装置 — Our patents protect our unique innovations in customized ostomy solutions and differentiated care designs.

微信图片_20220511103515 — ISO 13485 certification demonstrates our globally recognized quality management system across the entire product lifecycle.

202021676390.1--一种新型可排气造口袋 — Our patents protect our unique innovations in customized ostomy solutions and differentiated care designs.

Address

Room1-8, 7th Floor, 7th Building Guannan Fuxing Medical Industrial Park, No.62 Guanggu Road, East Lake New Technology Development Zone Wuhan City, Hubei Province, China