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Sign in to claim this brandGENADYNE BIOTECHNOLOGIES, INC.
United States·US-MF-000017992
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 16 Midland Ave, Hicksville, United States
- Website
- www.genadyne.com
- —
- —
- [email protected]
- Phone
- +15164878787
- PRRC Contact
- Andrew Goh
- EUDAMED SRN
- US-MF-000017992
- FDA FEI Number
- 1000137514
- DUNS Number
- —
Catalogue (95)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| White PVA Foam Small | XF-PVASFOAM1 | EUDAMEDFDA UDI | Class II | Active |
| UNO 15 Therapy Kit 10x30 | U-S1030-5 | FDA UDI | Class II | Active |
| UNO 30 Therapy Kit 10x40 | U-S1040-6 | FDA UDI | Class II | Active |
| Hybrid Dressing | UP-D1530/5 | FDA UDI | Class II | Active |
| UNO 10x20 Dressing Kit | UNO-0408 | EUDAMEDFDA UDI | Class II | Active |
| UNO 15 Therapy Kit 10x20 | U-S1020-5 | FDA UDI | Class II | Active |
| Bridge Dressing | XF-BDMF1 | EUDAMEDFDA UDI | Class II | Active |
| Hybrid Dressing | UP-D1520/5 | FDA UDI | Class II | Active |
| Spiro Foam Dressing Small | XF-SPSF1 | FDA UDI | Class II | Active |
| Foam Kit Medium | XF-DMDF1 | FDA UDI | Class II | Active |
| PVA Foam Kit Large | PVA-LFOAM1 | EUDAMEDFDA UDI | Class II | Active |
| UNO 15 Therapy Kit 20x20 | U-S2020-5 | FDA UDI | Class II | Active |
| XLR8 Transparent Film Dressing | A4-S00F5 | FDA UDI | Class II | Active |
| UNO 7 Therapy Kit 20x20 | U-S2020-4 | FDA UDI | Class II | Active |
| UNO 7 Therapy Kit 10x30 | U-S1030-4 | EUDAMEDFDA UDI | Class II | Active |
| UNO 30 Therapy Kit 10x20 | U-S1020-6 | FDA UDI | Class II | Active |
| UNO Plus 300 CC Collection Canister | UP-S00D3 | EUDAMEDFDA UDI | Class II | Active |
| UNO 7 Therapy Kit 25x25 | U-S2525-4 | FDA UDI | Class II | Active |
| XLR8 Canister | A4-S00D11 | EUDAMEDFDA UDI | Class II | Active |
| XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | K142646 | FDA 510(k) | Class II | Active |
| Genadyne Spiro Foam Dressing Kit | K141961 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Melodi Prime Breast Pump | K143574 | FDA 510(k) | Class II | Active |
| Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | K243225 | FDA 510(k) | Class II | Active |
| Genadyne DUO NPWT | K233614 | FDA 510(k) | Class II | Active |
| UNO Negative Pressure Wound Therapy System | K221891 | FDA 510(k) | Class II | Active |
| Genadyne A4 Wound Vacuum System | K082676 | FDA 510(k) | Class II | Active |
| UNO Negative Pressure Wound Therapy System | K161599 | FDA 510(k) | Class II | Active |
| Uno 30 | K190028 | FDA 510(k) | Class II | Active |
| Genadyne A4-Xlr8 Wound Vacuum System | K090638 | FDA 510(k) | Class II | Active |
| XLR8 Abdominal Wound Dressing Kit | K182722 | FDA 510(k) | Class II | Active |
| Xlr8 Plus (xlr8+) | K143726 | FDA 510(k) | Class II | Active |
| Lucina Model Melodi | K102516 | FDA 510(k) | Class II | Active |
| Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | K210107 | FDA 510(k) | Class II | Active |
| Xlr8 Plus (xlr8+) | K141437 | FDA 510(k) | Class II | Active |
| Genadyne A4 Powered Suction Pump | K080745 | FDA 510(k) | Class II | Active |
| Genadyne Hybrid Foam Dressings | K221888 | FDA 510(k) | Class II | Active |
| A4-Xlr8 Foam Dressing | K092992 | FDA 510(k) | Class II | Active |
| UNO Negative Pressure Wound Therapy System | K180840 | FDA 510(k) | Class II | Active |
| Genadyne ASTRA NPWT | K253429 | FDA 510(k) | Class II | Active |
| Lucina-Melodi | K112856 | FDA 510(k) | Class II | Active |
| Genadyne UNO | 00849405001607 | EUDAMEDFDA UDI | Class IIa | Active |
| Genadyne UNO | U-S0006 | EUDAMEDFDA UDI | Class IIa | Active |
| Genadyne UNO | U-S00R5 | EUDAMEDFDA UDI | Class IIa | Active |
| Genadyne Uno | U-S0005 | EUDAMEDFDA UDI | Class IIa | Active |
| Genadyne Uno | U-S00R6 | EUDAMEDFDA UDI | Class IIa | Active |
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