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Functional endotracheal intubation - NMPA Registration 豫械注准20182080101

Access comprehensive regulatory information for Functional endotracheal intubation 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20182080101 and owned by Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.. The device was approved on November 17, 2022.

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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NMPA Official Data
Class II
豫械注准20182080101
Functional endotracheal intubation
功能型气管插管
NMPA Registration Number: 豫械注准20182080101
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Intended Use
English

It is suitable for general anesthesia, artificial ventilation or other assisted breathing when inserted into the human throat to maintain airway ventilation.

中文

适用于全身麻醉,人工通气或其他辅助呼吸时插入人体咽喉部维持气道通气。

Device Classification
Device Class
Class II
Model Specifications
Model: Type I (ordinary administration type), Type II (ordinary sputum suction), Type III (enhanced administration type), Type IV (enhanced sputum suction), specifications: 2.0#, 2.5#, 3.0#, 3.5#, 4.0#, 4.5#, 5.0#, 5.5#, 6.0#, 6.5#, 7.0#, 7.5#, 8.0#, 8.5#, 9.0#, 9.5#, 10.0#, 10.5#, 11.0#
型号:I型(普通给药型)、II型(普通吸痰型)、III型(加强给药型)、IV型(加强吸痰型);规格:2.0#、2.5#、3.0#、3.5#、4.0#、4.5#、5.0#、5.5#、6.0#、6.5#、7.0#、7.5#、8.0#、8.5#、9.0#、9.5#、10.0#、10.5#、11.0#
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20182080101
Approval Date
November 17, 2022
Expiry Date
February 28, 2028
Registrant
Name
Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.
河南省健琪医疗器械有限公司
Province/Region
Henan
河南
Address
Dingluan Industrial Zone, Changyuan City
长垣市丁栾工业区
Production Facility
Production Address
长垣市丁栾工业区
Structure and Composition
English

Type I (ordinary drug delivery type) consists of: machine end joint, drug delivery connector, connecting tube, check valve, indicator balloon, inflatable tube, main tube, drug cuff, drug hole, Murphy hole, main tube cuff; Type II (ordinary suction type) consists of: machine end joint, sputum suction joint, suction joint cap, connecting pipe, check valve, indicator balloon, inflatable tube, main tube, suction hole, Murphy hole, main tube sleeve; Type III (enhanced drug delivery type) consists of: machine end joint, drug delivery joint, connecting tube, check valve, indicator balloon, inflatable tube, main tube, spring, drug cuff, drug hole, Murphy hole, main tube sleeve; Type IV (enhanced suction type) consists of: machine end joint, suction joint, suction joint cap, connecting tube, check valve, indicator balloon, inflatable tube, main tube, spring, suction hole, Murphy hole, main tube sleeve.

中文

I型(普通给药型)由:机器端接头、给药接头、连接管、单向阀、指示球囊、充气管、主体管、给药套囊、给药孔、墨菲孔、主体管套囊组成;II型(普通吸痰型)由:机器端接头、吸痰接头、吸痰接头帽、连接管、单向阀、指示球囊、充气管、主体管、吸痰孔、墨菲孔、主体管套囊组成;III型(加强给药型)由:机器端接头、给药接头、连接管、单向阀、指示球囊、充气管、主体管、弹簧、给药套囊、给药孔、墨菲孔、主体管套囊组成;IV型(加强吸痰型)由:机器端接头、吸痰接头、吸痰接头帽、连接管、单向阀、指示球囊、充气管、主体管、弹簧、吸痰孔、墨菲孔、主体管套囊组成。

Additional Information
Remark
原注册证编号:豫械注准20182660101 本注册证自“2023年03月01日”生效