FDA Registration
Active
🇨🇳 China
DEEPVESSEL FFR
Reg #: 3025430791
·
FEI: 3025430791
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KEYA MEDICAL TECHNOLOGY CO.,LTD.
- Registration Number
- 3025430791
- FEI Number
- 3025430791
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.1502, Floor 15, Building 1 , Yard No.1, Ronghua South Road, Beijing Economic-Technological Development Area
- City
- Beijing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213657
Owner / Operator
- Firm Name
- Keya Medical Technology Co.,Ltd.
- Operator Number
- 10086516
- Address
- No.1502, Floor 15, Building 1 , Yard No.1, Ronghua South Road, Beijing Economic-Technological Development Area
- City
- Beijing
- State
- CN-BJ
- Postal Code
- 100000
- Country
- CN
- Correspondent
- Yingguang Li
US Agent
- Business Name
- KeyaMed NA Inc.
- Contact Name
- Mary Waiss
- Address
- 107 Spring Street,Seattle, WA
- City
- Seattle
- State
- WA
- ZIP
- 98104
- Country
- US
- [email protected]
- Phone
- 425 4780433
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronary Vascular Physiologic Simulation Software | PJA | Class 2 | Cardiovascular | No | 2022-11-15 |
Proprietary Names
DEEPVESSEL FFR
Establishment Types
Manufacture Medical Device