China NMPA legacy archive 国械注准20233141041Silicone Foam Dressing
- Device class
- Class III
- Model specifications
- Model: Type I., II.-Edged Type, II.-Edgeless TypeSpecifications: 4×5, 5×5, 5×12.5, 6×7, 6×12, 7.5×7.5, 7.5×8.5, 8×8, 8×15, 10×10, 10×12, 10×15, 10×20, 10×22, 10×25, 10×30, 12.5×12.5, 12.5×20, 13×13, 14×21, 15×15, 15×18, 15×20, 18×18, 18×20、20×20、20×22、20×50、22.5×22.5.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20233141041
- Approval date
- July 28, 2023
- Expiry date
- July 27, 2028
- Province/Region
- Henan
- Address
- Changyuan City Nanpu Street Office Weiqi Road Middle Road South
- Production address
- 长垣市满村工业区
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。
- Appendix
- 产品技术要求
This static archive preserves historical registration fields and translations for Silicone Foam Dressing, registration 国械注准20233141041. It does not establish current authorization or complete current product details.
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