FDA Registration
Active
🇨🇳 China
PVC Hydrophilic Urethral Catheter
Reg #: 3023329815
·
FEI: 3023329815
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Chengdu Daxan Innovative Medical Tech. Co., Ltd.
- Registration Number
- 3023329815
- FEI Number
- 3023329815
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- East side of distribution Center 3,No.566,West Section of Kexing Road, Wenjiang District
- City
- chengdu Sichuan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212567
Owner / Operator
- Firm Name
- Chengdu Daxan Innovative Medical Tech. Co., Ltd.
- Operator Number
- 10086949
- Address
- East side of distribution Center 3,No.566,West Section of Kexing Road, Wenjiang District
- City
- Chengdu
- State
- Sichuan
- Postal Code
- 611137
- Country
- CN
- Correspondent
- Zeng Wei
US Agent
- Business Name
- ICAS Biologics Co.Ltd.
- Contact Name
- Sarah Galemmo
- Address
- 20 Via Lucca D310 Irvine
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 661 8033155
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2022-12-26 |
Proprietary Names
PVC Hydrophilic Urethral Catheter
Establishment Types
Manufacture Medical Device