FDA Registration
Active
🇺🇸 United States
Ensemble II Transcatheter Valve Delivery System
Reg #: 1318694
·
FEI: 1318694
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NUMED, INC.
- Registration Number
- 1318694
- FEI Number
- 1318694
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2880 MAIN ST.
- City
- Hopkinton
- State
- NY
- ZIP
- 12965
- Country
- US
Regulatory Submissions
- PMA Number
- P140017
Owner / Operator
- Firm Name
- NUMED, INC.
- Operator Number
- 1318694
- Address
- 2880 MAIN ST., --
- City
- Hopkinton
- State
- NY
- Postal Code
- 12965
- Country
- US
- Correspondent
- NICHELLE R LAFLESH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pulmonary Valve Prosthesis Percutaneously Delivered | NPV | Class f | Unknown | No | 2015-02-13 |
Proprietary Names
Ensemble II Transcatheter Valve Delivery System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)