Identity
- Trade Name
- Medifoam FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
- Device Name
- Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasions, etc. It readily absorbs exudate, providing a moist wound interface that produces an optimal wound healing environment. To help adhesion, a non-woven fabric for fixation is enclosed with the product. Medifoam is a sterile, but Non-woven fabric is a non-sterile. This is single-use product, do not re-use. This product does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. FDA UDI
- Model / Reference
- 12NL02 FDA UDI
- Description
- Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasions, etc. It readily absorbs exudate, providing a moist wound interface that produces an optimal wound healing environment. To help adhesion, a non-woven fabric for fixation is enclosed with the product. Medifoam is a sterile, but Non-woven fabric is a non-sterile. This is single-use product, do not re-use. This product does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806129660031 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Exudate-absorbent dressing, non-gel, non-antimicrobial
Medifoam by Genewel Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Genewel Co., Ltd.
Sources (1)
- FDA UDI 7603b3e3-9ecb-49ed-9087-fcf80671941b 33 fields · synced Jun 1, 2026