FDA Registration
Active
🇺🇸 United States
Genadyne Biotechnologies, Inc.
Reg #: 3011582224
·
FEI: 3011582224
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Genadyne Biotechnologies, Inc.
- Registration Number
- 3011582224
- FEI Number
- 3011582224
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 519 Johnson Ave
- City
- Bohemia
- State
- NY
- ZIP
- 11716
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141961
Owner / Operator
- Firm Name
- GENADYNE BIOTECHNOLOGIES, INC.
- Operator Number
- 9006819
- Address
- 16 MIDLAND AVENUE, --
- City
- Hicksville
- State
- NY
- Postal Code
- 11801
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2014-06-19 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2015-04-30 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2025-01-07 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2020-12-16 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2015-04-09 |
Proprietary Names
Nanogen Aktigel
Nanogen Aktiv
Algen
Spiro Foam Dressing Kit
UNO Negative Pressure Wound Therapy
UNO
Nefes CPAP Nasal Pillow Mask
UNO+
XLR8 White Foam Dressing Kit
DUO
XLR8 Foam Dressing
Gena Foam
Gentil Foam
Gentiltac
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device