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Polyvinyl alcohol enclosed trauma negative pressure drainage set - NMPA Registration 豫械注准20232140930

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.

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Class II
豫械注准20232140930
Polyvinyl alcohol enclosed trauma negative pressure drainage set
聚乙烯醇封闭创伤负压引流套装
NMPA Registration Number: 豫械注准20232140930
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Intended Use
English

It is used to drain non-chronic wounds (eg, suture wounds after surgery, mechanical trauma, cut wounds, superficial burn wounds).

中文

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。

Device Classification
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 Information
Registration Number
豫械注准20232140930
Approval Date
December 12, 2023
Expiry Date
December 11, 2028
Registrant
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 Facility
Production Address
长垣市满村工业区
Structure and Composition
English

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.

中文

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。

Additional Information
Appendix
产品技术要求