UNO 10x20 Dressing Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- UNO 10x20 Dressing EUDAMEDUNO 15x20 Dressing EUDAMEDUNO 10x20 Dressing Kit FDA UDIUNO 15x20 Dressing Kit FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, single-use FDA UDINegative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- UNO 10x20 Dressing kit EUDAMEDUNO 15x20 Dressing kit EUDAMEDThe UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is attached to. The 2nd layer is a super absorbent layer, 3rd layer is a foam layer, and the bottom layer that is skin/ wound contacting is a silicone gel adhesive layer. FDA UDI
- Model / Reference
- UNO-0408 EUDAMEDFDA UDIUNO-0608 EUDAMEDFDA UDI
- Description
- The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is attached to. The 2nd layer is a super absorbent layer, 3rd layer is a foam layer, and the bottom layer that is skin/ wound contacting is a silicone gel adhesive layer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405021513 EUDAMEDFDA UDI00849405021551 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405021513 EUDAMEDB-00849405021551 EUDAMED
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Negative-pressure wound therapy system, electric, single-use FDA UDINegative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Negative-pressure wound therapy system, electric, single-use
UNO 10x20 Dressing Kit by Genadyne Biotechnologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
Sources (4)
- FDA UDI 9d0ef007-f810-4ee3-be8d-e6f9e888cd42 33 fields · synced Jul 28, 2026
- FDA UDI 738682a6-a8b1-4edb-a0a3-6502cd9b877a 33 fields · synced May 30, 2026
- EUDAMED acddb128-a083-41d5-bd4c-8a2b0d4a823b 61 fields · synced Jul 24, 2026
- EUDAMED aa131e14-85ca-4457-bad1-08df876640d4 61 fields · synced Jul 28, 2026