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Sign in to claim this brandDERMARITE INDUSTRIES LLC
US
Last updated May 31, 2026
What DERMARITE INDUSTRIES LLC makes
DermaRite Industries LLC manufactures wound care dressings, including non-gel and gel-based exudate-absorbent products, both antimicrobial and non-antimicrobial variants, as well as nonadherent and absorbent wound dressings. Their portfolio also includes adhesive bandages, synthetic polymer film dressings (adhesive and nonadherent), and specialized dressings like oil emulsion and foam-based solutions for wound management.
The company’s devices are classified under FDA categories including Class I, Class II, and Class II with special controls (U), with all products listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for medical device compliance.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DermaRite Industries LLC manufacture?
DermaRite Industries LLC specializes in wound care dressings, covering a range of product categories. These include exudate-absorbent dressings (both non-gel and gel-based, with antimicrobial and non-antimicrobial options), wound-nonadherent dressings (permeable and absorbent), adhesive bandages, and synthetic polymer semi-permeable film dressings (adhesive and nonadherent). Their portfolio also features specialized dressings like oil emulsion and foam-based solutions, all designed for wound management.
Where is DermaRite Industries LLC based, and how does this affect its devices?
DermaRite Industries LLC is based in the United States, which means its devices are subject to U.S. regulatory requirements, including compliance with FDA guidelines. The company’s location ensures its products meet the necessary standards for safety, performance, and quality as defined by U.S. medical device regulations.
Which regulatory registries list DermaRite Industries LLC’s devices?
DermaRite Industries LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to identify and verify specific products.
How are DermaRite Industries LLC’s devices classified under FDA regulations?
DermaRite Industries LLC’s devices fall under different FDA classification categories, including Class I (generally low-risk devices with minimal regulatory controls), Class II (devices requiring special controls to ensure safety and effectiveness), and Class II with special controls (U), which involves additional regulatory oversight due to higher risk or complexity. The classification depends on factors like the device’s intended use, potential risks, and the level of regulation required for patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dermarite.com
- —
- —
- [email protected]
- Phone
- 800-337-6296
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 883925562
Catalogue (423)
Page 6 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bordered Gauze | 00256 | FDA UDI | Class I | Active |
| ComfortFoam/Ag Border | 48220 | FDA UDI | U | Active |
| Dermafilm Thin w/ Border, Triangle Healogics by DermaRite | 93438 | FDA UDI | Class I | Active |
| ComfortFoam | 44450 | FDA UDI | Class I | Active |
| ComfortFoam Border | 43220 | FDA UDI | Class I | Active |
| ComfortFoam | 44880 | FDA UDI | Class I | Active |
| DermaDress | 00276E | FDA UDI | Class I | Active |
| DermaSyn | 11246 | FDA UDI | Class I | Active |
| Xeroform Gauze Dressing | 24440 | FDA UDI | Class I | Active |
| AquaRite Extra CMC | 40660 | FDA UDI | Class I | Active |
| ComfortFoam | 44680 | FDA UDI | Class I | Active |
| DermaDress | 12414 | FDA UDI | Class I | Active |
| AquaDerm | 00322E | FDA UDI | Class I | Active |
| DermaView II Transparent Dressing | 16410 | FDA UDI | Class I | Active |
| ComfortFoam Border Lite | 47220 | FDA UDI | Class I | Active |
| DermaBlue + Foam | 76020214 | FDA UDI | U | Unknown |
| DermaFilm X-Thin Clear with Grid | 00219E | FDA UDI | Class I | Active |
| DermaFilm Thin with Border | 00306E | FDA UDI | Class I | Active |
| Sterile Bordered Gauze | 11480 | FDA UDI | Class I | Active |
| DermaFilm Sacral | 00279E | FDA UDI | Class I | Active |
| DermaCol/Ag Healogics by DermaRite | 93352 | FDA UDI | U | Active |
| DermaBlue + Foam | 72040414 | FDA UDI | U | Unknown |
| Sterile Bordered Gauze | 00262E | FDA UDI | Class I | Active |
| UnnaRite | 78410Z | FDA UDI | Class I | Active |
| ComfortFoam Healogics by DermaRite | 93195 | FDA UDI | Class I | Active |
| ComforFoam Border Sacral | 43990 | FDA UDI | Class I | Active |
| DermaGinate | 00270E | FDA UDI | Class I | Active |
| DermaPrep Skin Prep Pads | 81050 | FDA UDI | Class I | Active |
| ComfortFoam | 00315E | FDA UDI | Class I | Active |
| Oil Emulsion Gauze Dressing Healogics by DermaRite | 93813 | FDA UDI | Class I | Active |
| ComfortFoam/Ag | 49660 | FDA UDI | U | Active |
| Xerofrom Gauze Dressing | 24180 | FDA UDI | Class I | Active |
| Oil Emulsion Dressing | 22330 | FDA UDI | Class I | Active |
| DermaView II | 00253E | FDA UDI | Class I | Active |
| ComfortFoam | 44220 | FDA UDI | Class I | Active |
| ComfortFoam/Ag Border | 48440 | FDA UDI | U | Active |
| DermaFilm Thin with Border | 00259E | FDA UDI | Class I | Active |
| ComfortFoam Border Healogics by Dermarite | 93213 | FDA UDI | Class I | Active |
| DermaFilm X-Thin Clear with Grid | 31110 | FDA UDI | Class I | Active |
| AquaDerm Healogics by DermaRite | 93032 | FDA UDI | Class I | Active |
| DermaView | 00241E | FDA UDI | Class I | Active |
| Oil Emulsion Gauze Dressing | 22316 | FDA UDI | Class I | Active |
| DermaView Transparent Film Roll | 15211 | FDA UDI | Class I | Active |
| DermaView II Island | 16340 | FDA UDI | Class I | Active |
| ComfortFoam Healogics by DermaRite | 93192 | FDA UDI | Class I | Active |
| DermaFilm X-Thin Clear with Grid | 31240 | FDA UDI | Class I | Active |
| AquaRite Ag Extra CMC | 46660 | FDA UDI | Class I | Unknown |
| Comfitel Healogics by DermaRite | 93173 | FDA UDI | Class I | Active |
| DermaCol 100 Sheet | 003341 | FDA UDI | U | Active |
| ComfortFoam/Ag Border | 48220 | FDA UDI | U | Active |
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