FDA Registration
Active
🇺🇸 United States
MBS-2034-1
Reg #: 2245270
·
FEI: 2245270
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VYGON USA
- Registration Number
- 2245270
- FEI Number
- 2245270
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2750 Morris Rd Suite A200
- City
- Lansdale
- State
- PA
- ZIP
- 19446
- Country
- US
Regulatory Submissions
- 510(k) Number
- K873957
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 |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2012-10-16 |
Proprietary Names
MBS-2034-1
MSY-2234-1
MBS-2210-1
MBS-2010
MBS-1910
MSY-2250
MSY-2034
MBS-2034
MBS-2234
MSY-2015
MSY-2210
MBS-2210
MSY-1910
MSY-2234
Non-coring Huber Set
MSY-2034-1
MBS-2234-1
MBS-2015
MSY-2010
MSY-2010-1
MBS-2010-1
MSY-1915
MBS-2250
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility