FDA Registration
Active
🇨🇳 China
Curatia Medical Limited
Reg #: 3008261722
·
FEI: 3008261722
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Curatia Medical Limited
- Registration Number
- 3008261722
- FEI Number
- 3008261722
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 198 Xiangjiang Road, New District
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K180797
Owner / Operator
- Firm Name
- Curatia Medical Co.
- Operator Number
- 10031704
- Address
- 830 Stewart Drive
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94085
- Country
- US
- Correspondent
- Jessica Chiu
US Agent
- Business Name
- Curatia Medical Co.
- Contact Name
- Jason Sun
- Address
- 830 Stewart Drive
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
- [email protected]
- Phone
- 408 7738839
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2019-02-11 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2017-08-03 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2010-03-01 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-05-04 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2017-03-01 |
Proprietary Names
Xcess Guiding Catheter
Vela RX PTA Balloon Dilatation Catheter
Ursa Angiographic Catheter
URSA ANGIOGRAPHIC CATHETER
EXTesia Introducer Sheath Set
Navajo PTA Balloon Dilatation Catheter
AutoSeal Hemostasis Valve
Establishment Types
Manufacture Medical Device