Silicone Foam Dressing - NMPA Registration 国械注准20233141041
Access comprehensive regulatory information for Silicone Foam Dressing in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20233141041 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on July 28, 2023.
This page provides complete registration details including registrant information, province location (Henan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This product is suitable for chronic wounds and wounds with exudate.
本产品适用于慢性创面及有渗出液创面。
Type I includes polyurethane film, core coating and isolation layer, wherein the core coating is composed of cellulose layer, non-woven layer, polyurethane foam layer and polysilicone layer. II.- The edged type includes polyurethane film, core coating and isolation layer, wherein the core coating is composed of polyurethane foam layer and polysilicone layer. II.- The edgeless type includes polyurethane film, core coating and isolation layer, wherein the core coating is composed of polyurethane foam layer and polysilicone layer. The product is sterilized by electron beam radiation and is used once.
Ⅰ型包括聚氨酯膜、敷芯和隔离层，其中敷芯由纤维素层、无纺布层、聚氨酯泡沫层、聚硅酮层组成。Ⅱ-有边型包括聚氨酯膜、敷芯和隔离层，其中敷芯由聚氨酯泡沫层、聚硅酮层组成。Ⅱ-无边型包括聚氨酯膜、敷芯和隔离层，其中敷芯由聚氨酯泡沫层、聚硅酮层组成。产品采用电子束辐射灭菌，一次性使用。