Product Overview:
Our Medical Polyurethane Hollow Plaster is a high-tech carrier designed for the customized delivery of powdered medicines, ointments, and liquid formulations. Manufactured from premium medical-grade Polyurethane (PU) film, this innovative patch serves as a "blank canvas" for compounding pharmacies, TCM clinics, and hospitals requiring personalized treatment solutions.
Production Details & Technical Specifications:

Manufacturer Advantages:
As a specialized OEM/ODM manufacturer in the medical device sector, we pride ourselves on vertical integration and stringent quality control. Our facility operates in compliance with ISO 13485:2016 standards, ensuring that every batch is produced under strict environmental monitoring. We utilize automated coating and slitting lines to guarantee uniform thickness and consistent peel adhesion (typically 1.0–2.0 N/cm). With over a decade of industry experience, we offer rapid prototyping and private labeling services to help healthcare brands launch their products efficiently. Our supply chain utilizes only virgin raw materials sourced from FDA-registered suppliers, ensuring stability and lot-to-lot consistency.
Certifications & Compliance:
Our Polyurethane Hollow Plasters are manufactured and registered in full compliance with international regulatory standards:
- FDA Registration: Our production facility and product dossiers are registered with the U.S. Food and Drug Administration.
- CE Marking (MDR): Certified under the European Medical Device Regulation (2017/745) for Class I medical devices.
- CFDA / NMPA Certification: Compliant with China's rigorous medical device standards (Product Technical Requirement Filing), holding a valid Medical Device Production License .
- ISO 10993 Biocompatibility: Materials have passed biological evaluation tests for cytotoxicity, sensitization, and irritation.
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