Polyvinyl alcohol enclosed trauma negative pressure drainage set
- Device class
- Class II
- Model specifications
- 型号:I.型、II.型;格:5×5×1、8×5×1、10×5×1、15×5×1、20×5×1、10×10×1、15×10×1、20×10×1、20×15×1、25×15×1、30×15×1、30×15×1、30×20×1、35×20×1、40×20×1、40×30×1、45×30×1、10×1.6×1、15×1.6×1、20×1.6×1、20×1.6×1型号:Ⅰ型、Ⅱ型;规格:5×5×1、8×5×1、10×5×1、15×5×1、20×5×1、10×10×1、15×10×1、20×10×1、20×15×1、25×15×1、30×15×1、30×20×1、35×20×1、40×20×1、40×30×1、45×30×1、10×1.6×1、15×1.6×1、20×1.6×1
- Approval department
- Henan Provincial Drug Administration河南省药品监督管理局
- Registration number
- 豫械注准20232140930
- Approval date
- December 12, 2023
- Expiry date
- December 11, 2028
- Name
- Henan Tuoren BEST MEDICAL Device Co., Ltd.河南驼人贝斯特医疗器械有限公司
- Province/Region
- Henan河南
- Address
- Changyuan City Nanpu Street Office Weiqi Road Middle Road South长垣市南蒲街道办事处纬七路中段路南
- Production address
- 长垣市满村工业区
It is used to drain non-chronic wounds (eg, suture wounds after surgery, mechanical trauma, cut wounds, superficial burn wounds).
用于对非慢性创面(如手术后缝合创面、机械创伤、切割伤创面、浅Ⅱ度的烧烫伤创面)进行引流。
Type I is composed of medical foam, drainage tube (built-in flushing tube), flow stop clamp, straight-through, tee, connecting pipe and negative pressure drainage sealing membrane, of which 1 drainage tube (built-in flushing tube), 1 stop clamp, 1 straight-through and 1 tee, and the medical foam is made of polyvinyl alcohol. Type II is composed of medical foam, drainage tube (built-in flushing tube), stop clamp, straight-through, tee, connecting pipe and negative pressure drainage sealing membrane, of which 2 drainage tubes (built-in flushing tubes), 2 stop clamps, 2 straight-through and 2 tees, and the medical foam is made of polyvinyl alcohol. The ingredients contained in it are not absorbed by the body.
Ⅰ型由医用泡绵、引流管(内置冲洗管)、止流夹、直通、三通、连接管、负压引流封闭膜组成,其中引流管(内置冲洗管)1根、止流夹1个、直通1个、三通1个,医用泡绵材质为聚乙烯醇。Ⅱ型由医用泡绵、引流管(内置冲洗管)、止流夹、直通、三通、连接管、负压引流封闭膜组成,其中引流管(内置冲洗管)2根、止流夹2个、直通2个、三通2个,医用泡绵材质为聚乙烯醇。所含成分不可被人体吸收。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Polyvinyl alcohol enclosed trauma negative pressure drainage set in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20232140930 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on December 12, 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.