Identity
- Trade Name
- UNO 15x30 Dressing EUDAMEDUNO 15x30 Dressing Kit FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- UNO 15x30 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-0612 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
- 00849405021568 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405021568 EUDAMED
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Negative-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 foam dressing, non-antimicrobial
UNO 15x30 Dressing Kit by Genadyne Biotechnologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 (2)
- FDA UDI b9a49f08-3f19-4517-9c75-ea2b8d051fb6 33 fields · synced Jun 20, 2026
- EUDAMED 2b48c102-502b-4ead-a9d0-5b17bacdc9ed 61 fields · synced Jun 20, 2026