FDA Registration
Active
🇺🇸 United States
HYDROFERA, LLC.
Reg #: 1225532
·
FEI: 3001236237
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- HYDROFERA, LLC.
- Registration Number
- 1225532
- FEI Number
- 3001236237
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 340 Progress Drive
- City
- Manchester
- State
- CT
- ZIP
- 06042
- Country
- US
Regulatory Submissions
- 510(k) Number
- K013462
Owner / Operator
- Firm Name
- HYDROFERA, LLC.
- Operator Number
- 9028346
- Address
- 340 Progress Drive, --
- City
- Manchester
- State
- CT
- Postal Code
- 06042
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2007-11-27 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 1998-03-24 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2011-12-09 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2018-06-21 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2008-01-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-12-09 |
| Ear Wick | KCN | Class 1 | Ear, Nose, Throat | No | 2018-07-03 |
Proprietary Names
Hydrofera Blue Classic
BACTERIOSTATIC NASAL
Hydrofera Blue Ready - Border
Hydrofera Instrument WIpe
Hydrofera Blue Transfer
Hydrofera Blue READY Antibacterial Foam Dressing
Hydrofera Blue Ready Transfer
Keel Sponge
Hydrofera Femoral Wick
Hydrofera Ear Wick
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)