FDA Registration
Active
🇺🇸 United States
Antimicrobial Barrier Film Dressing
Reg #: 1130591
·
FEI: 1130591
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Aphena Pharma Solutions - Maryland, LLC
- Registration Number
- 1130591
- FEI Number
- 1130591
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7978 Industrial Park Rd
- City
- EASTON
- State
- MD
- ZIP
- 21601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161212
Owner / Operator
- Firm Name
- Aphena Pharma Solutions
- Operator Number
- 10030446
- Address
- 7978 Industrial Park Rd
- City
- Easton
- State
- MD
- Postal Code
- 21601
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2017-04-24 |
Proprietary Names
Antimicrobial Barrier Film Dressing
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)