FDA Registration
Active
🇺🇸 United States
PPS-2275
Reg #: 1223004
·
FEI: 1000120555
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Vygon MFG
- Registration Number
- 1223004
- FEI Number
- 1000120555
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 87 Venture Dr
- City
- DOVER
- State
- NH
- ZIP
- 03820
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063631
Owner / Operator
- Firm Name
- VYGON USA
- Operator Number
- 2245270
- Address
- 2750 Morris Road, Suite A200
- City
- Lansdale
- State
- PA
- Postal Code
- 19446
- Country
- US
- Correspondent
- Chris Steinke
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2023-02-17 |
Proprietary Names
PPS-2275
PPS-2010
PPS-2210
PPS-2075
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)