Single-use polyurethane balloon enhanced endotracheal tube set
- Device class
- Class II
- Model specifications
- 型号:标准型 规格:3.0mm、3.5mm、4.0mm、4.5mm、5.0mm、5.5mm、6.0mm、6.5mm、7.0mm、7.5mm、8.0mm、8.5mm、9.0mm、9.5mm;型号:牙垫型 规格:6.0mm、6.5mm、7.0mm、7.5mm、8.0mm; 型号:带吸痰腔型 规格:6.0mm、6.5mm、7.0mm、7.5mm、8.0mm、8.5mm、9.0mm.型号：标准型 规格：3.0mm、3.5mm、4.0mm、4.5mm、5.0mm、5.5mm、6.0mm、6.5mm、7.0mm、7.5mm、8.0mm、8.5mm、9.0mm、9.5mm；型号：牙垫型 规格：6.0mm、6.5mm、7.0mm、7.5mm、8.0mm； 型号：带吸痰腔型 规格：6.0mm、6.5mm、7.0mm、7.5mm、8.0mm、8.5mm、9.0mm。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20232081974
- Approval date
- November 29, 2023
- Expiry date
- November 28, 2028
- Name
- Well Lead Medical Co., Ltd.广州维力医疗器械股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 4, Area C, Jinhu Industrial City, Hualong Town, Panyu District, Guangzhou广州市番禺区化龙镇金湖工业城C区4号
- Production address
- 地址1：广州市番禺区化龙镇金湖工业城C区4号，地址2：广州市番禺区化龙镇国贸大道南45号、47号
It is intended for one-time use when the medical department performs endotracheal intubation on patients.
供医疗部门对患者实施气管插管术时一次性使用。
Single-Use Polyurethane Balloon Strengthened Endotracheal Intubation Kit includes Disposable Polyurethane Balloon Strengthened Endotracheal Intubation (Standard, Dental Pad, with Suction Cavity), Endotracheal Intubation Clip (Optional), Mouthpiece (Optional), Balloon Inflator (Optional), Suction Catheter for Respiratory Tract (Optional), Suction Connecting Tube, Medical Rubber Gloves, Medical Absorbent Gauze, Nonwoven Fabric (Drape), Intubation Guidewire (Optional), Bandage (Optional), Adhesive Patch (Optional), Oropharyngeal Airway (Optional), Peep sheet (optional) composition.
一次性使用聚氨酯球囊加强型气管插管套件包括一次性使用聚氨酯球囊加强型气管插管（标准型、牙垫型、带吸痰腔型）、气管插管固定夹（选配）、咬嘴（选配）、球囊充起器（选配）、呼吸道用吸引导管（选配）、吸引器连接管、医用橡胶手套、医用脱脂纱布、非织造布（铺巾）、插管导丝（选配）、绷带（选配）、胶贴（选配）、口咽通气道（选配）、窥视片（选配）组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Single-use polyurethane balloon enhanced endotracheal tube 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 粤械注准20232081974 and owned by Well Lead Medical Co., Ltd.. The device was approved on November 29, 2023.
This page provides complete registration details including registrant information, province location (Guangdong), 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.