FDA Registration
Active
🇨🇳 China
Cuffed Endotracheal tube, Size(I.D):2.5,3,3.5,4,4.5,5,5.5,6,6.5,7,7.5,8,8.5,9,9.5,10
Reg #: 3014101089
·
FEI: 3014101089
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZHANJIANG STAR ENTERPRISE CO., LTD
- Registration Number
- 3014101089
- FEI Number
- 3014101089
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO.1, West Jinhua Road, Mazhang District
- City
- Zhanjiang Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K170234
Owner / Operator
- Firm Name
- Zhanjiang Star Enterprise Co.,Ltd
- Operator Number
- 10056077
- Address
- NO.1, West Jinhua Road, Mazhang District
- City
- Zhanjiang
- State
- Guangdong
- Postal Code
- 524094
- Country
- CN
- Correspondent
- Hetian San
US Agent
- Business Name
- Shenzhen Joyantech Consulting Co., Ltd.
- Contact Name
- Thomas Tang
- Address
- 25 Hopewell Drive Stony Brook
- City
- Stony Brook
- State
- NY
- ZIP
- 11790
- Country
- US
- [email protected]
- Phone
- 631 7511103
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2018-01-29 |
Proprietary Names
Cuffed Endotracheal tube, Size(I.D):2.5,3,3.5,4,4.5,5,5.5,6,6.5,7,7.5,8,8.5,9,9.5,10
Cuffed Reinforced Endotracheal tube, Size(I.D)3,3.5,4,4.5,5,5.5,6,6.5,7,7.5,8,8.5,9
Uncuffed Endotracheal tube, Size(I.D)2.5,3,3.5,4,4.5,5,5.5,6,6.5,7,7.5,8,8.5,9,9.5,10
Uncuffed Reinforced Endotracheal tube,Size(I.D)3,3.5,4,4.5,5,5.5,6,6.5,7,7.5,8,8.5,9
Establishment Types
Manufacture Medical Device