FDA Registration
Active
🇺🇸 United States
GENADYNE BIOTECHNOLOGIES, INC.
Reg #: 2435947
·
FEI: 1000137514
·
Expires 2026
Products
13
Proprietary Names
25
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- GENADYNE BIOTECHNOLOGIES, INC.
- Registration Number
- 2435947
- FEI Number
- 1000137514
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 16 Midland Ave
- City
- Hicksville
- State
- NY
- ZIP
- 11801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102516
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 |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2012-06-27 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2012-06-27 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2003-06-26 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 1998-03-25 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2025-01-07 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 1998-03-25 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2020-12-16 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2020-07-28 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2001-09-07 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2015-04-13 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2014-06-19 |
| Pump, Nebulizer, Electrically Powered | JPW | Class 1 | Ear, Nose, Throat | No | 1997-06-27 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2015-04-09 |
Proprietary Names
Lucina Melodi Advance Breast pump
XLR8 Foam Dressing
Genadyne XLR8+ Negative Pressure Wound Therapy System
GENAIR 8000 PLUS SERI
Genadyne A4 Negative Pressure Wound Therapy
LX
DX
GENTRACK STD
Genadyne XLR8 Negative Pressure Wound Therapy System
Lucina Melodi Advance Plus Breast Pump
ACTIVE CHANNEL TECHNOLOGIES
DUO
UNO
Silgen AG Spray
ZONE SEATING SYSTEMS
Hydrogen
Nanogen Aktigel
Nanogen Aktiv
Algen
ACT ACTIVE CHANNEL TECHNOLGIES
Gena Foam
Gentil Foam
Gentiltac
UNO Negative Pressure Wound Therapy
UNO+
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only