Single-use enhanced flexible endotracheal tubing kit
- Device class
- Class II
- Model specifications
- Model: Cuffed (PU Balloon), Cuffed (PVC Balloon) Size: 3.0mm, 3.5mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm,7.5 mm,8.0 mm,8.5 mm,9.0 mm,9.5 mm; Model: Without cuff Size: 3.0mm, 3.5mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm.型号：带套囊（PU 球囊）、带套囊（PVC 球囊） 规格：3.0mm，3.5mm，4.0 mm，4.5 mm，5.0 mm，5.5 mm，6.0 mm，6.5 mm， 7.0 mm，7.5 mm，8.0 mm，8.5 mm，9.0 mm，9.5 mm； 型号：不带套囊 规格：3.0mm，3.5mm，4.0 mm，4.5 mm，5.0 mm，5.5 mm，6.0 mm，6.5 mm， 7.0 mm。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20232081605
- Approval date
- September 28, 2023
- Expiry date
- September 27, 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
- Address 1: No. 4, Area C, Jinhu Industrial City, Hualong Town, Panyu District, Guangzhou City, Address 2: No. 45 and No. 47, Guomao Avenue South, Hualong Town, Panyu District, Guangzhou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
- 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。
The Single-Use Enhanced Flexible Endotracheal Intubation Kit includes a single-use Enhanced Flexible Endotracheal Intubation (with cuff (PU balloon), with cuff (PVC balloon), without cuff), endotracheal intubation clip (optional), mouthpiece (optional), syringe (inflatable, 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 tape (optional), oropharyngeal airway (optional), Peep sheet (optional) composition.
一次性使用加强型柔性气管插管套件包括一次性使用加强型柔性气管插管(带套囊（PU 球囊）、带套囊（PVC 球囊）、不带套囊)、气管插管固定夹（选配）、咬嘴（选配）、注射器（充气用，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 enhanced flexible endotracheal tubing kit 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20232081605 and owned by Well Lead Medical Co., Ltd.. The device was approved on September 28, 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.