ISO 13485 IA50 Tip Silicone Nasal Implants Prosthesis

Nasal Prosthesis - IA50 Style Silicone Facial Subcutaneous implants

The silicone facial subcutaneous implants are developed by a team of experts with professional medical knowledge. Using the medical silicone rubber polymer materials and basing on the head bone characteristics, our facial implants have been designed to multipule modes, could be used in plastic surgery without carving.

IA Style product is made of high grade meidcal silicone gel material. The soft nasal implant has L style wihch fits nasal profile. It can be used in surgery without carving

Specifications:

Guangzhou Wanhe Plastic Materials Co., Ltd. (referred to as “Wanhe”), founded in 1996, is a high-tech enterprise specializing in researching, developing and manufacturing silicone plastic medical devices. Our current product line includes silicone gel-filled breast implants, silicone facial subcutaneous implants, tissue expander for single use, medical silicone-gel sheet and nostril retaine. With the high-quality products and services for over twenty years, Wanhe has achieved a tremendous level of respect from the experts and the industry.

Since the date of establishment, Wanhe focuses on the construction of the quality management system. Wanhe has successively passed ISO 9001 & ISO 13485 quality system certification in 2002, manufacturing quality management assessment organized by Guangdong Food and Drug Administration in 2009, good manufacturing practice (GMP) inspection organized by Guangdong Food and Drug Administration in 2011 and RDC/61-2000 certification by Brazil National Health Surveillance Agency (ANVISA) in 2012. Wanhe has established a service management system for product R&D, manufacturing, inspection and sale as well as an after-sale surveillance system. The scientific management ensures to provide the customers with the first-class products and service.

Production base

Production workshop	R&D Building	R&D Building

GMP standard purification area GMP

Purification workshop	Production equipment	product testing

Wanhe concentrates on the improvement of product quality and the research and development of new products. With a fully equipped manufacturing base, a cleanroom in Class 10000 and 100000, advanced production and inspection devices and apparatus, Wanhe can strictly control the product quality and provide a good environment for product research, development and production. Since the products have been put into market, the market share of Wanhe has grown steadily and the products have gained the recognition of surgeons and patients in Brazil, Colombia, Russia, Taiwan and other countries and regions.