FDA Registration
Active
🇨🇳 China
Monitor for Single-Use Endoscopy, P1-A, P1-B, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E
Reg #: 3030504644
·
FEI: 3030504644
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD
- Registration Number
- 3030504644
- FEI Number
- 3030504644
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4th floor, Building 10, Innovation and Entrepreneurship Center, No. 31, Dongfeng Road, Heping Street, Xiangtan
- City
- XiangTan Hunan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231107
Owner / Operator
- Firm Name
- Hunan Endoso Life Technology Co., Ltd
- Operator Number
- 10089503
- Address
- 4th floor, Building 10, Innovation and Entrepreneurship Center, No. 31, Dongfeng Road, Heping Street, Xiangtan
- City
- XiangTan
- State
- Hunan
- Postal Code
- 411199
- Country
- CN
- Correspondent
- Fu Wang
US Agent
- Business Name
- ZYPPEL LLC
- Contact Name
- Qihui Zhang
- Address
- 1337 Mass Ave Pmb 158
- City
- Arlington
- State
- MA
- ZIP
- 02476
- Country
- US
- [email protected]
- Phone
- 617 2991655
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-02-29 |
Proprietary Names
Monitor for Single-Use Endoscopy, P1-A, P1-B, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E
Single-use Bronchoscope, BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3
Establishment Types
Manufacture Medical Device