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Sign in to claim this brandWhat FARMSKIN Inc. makes
Farmskin Inc. manufactures exudate-absorbent dressings designed with hydrophilic gel and without antimicrobial properties, as well as antimicrobial skin semi-occlusive dressings. Their product line includes multiple variants of the Troubless brand, which are intended for wound care applications.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
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 FARMSKIN Inc. manufacture?
FARMSKIN Inc. specializes in wound care dressings. Their product line includes two primary categories: exudate-absorbent dressings made with hydrophilic gel and without antimicrobial properties, as well as antimicrobial skin semi-occlusive dressings. These are designed to manage wound exudate and promote healing in various clinical settings.
Where is FARMSKIN Inc. based, and how does that affect its regulatory landscape?
FARMSKIN Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes FARMSKIN’s products, which helps ensure traceability and compliance with U.S. medical device requirements.
Which regulatory registries or databases list FARMSKIN Inc.’s devices?
FARMSKIN Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the U.S., ensuring transparency and regulatory oversight for authorized products.
How are FARMSKIN Inc.’s devices classified under FDA regulations?
FARMSKIN Inc.’s devices are classified as Class I under FDA regulations. This classification typically applies to low-risk medical devices that pose minimal potential harm to users. Class I devices still require compliance with FDA requirements, including proper labeling and manufacturing controls, but they do not undergo the same rigorous pre-market review as higher-risk categories.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- cdri.pro
- —
- —
- [email protected]
- Phone
- 1-888-243-7218
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 694867229
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Troubless | Troubless MICRO-POINT PATCH | FDA UDI | Class I | Active |
| Troubless | Troubless INVISIBLE PLUS SPOT PATCH THE RED CORRECT | FDA UDI | Class I | Active |
| Troubless | Troubless MICRO-POINT PATCH PLUS LIMITED VALUE PACK | FDA UDI | Class I | Active |
| Troubless | Troubless INVISIBLE PLUS SPOT PATCH THE SIGNATURE | FDA UDI | Class I | Active |
| Troubless | Troubless INVISIBLE PLUS SPOT PATCH THE CLASSIC | FDA UDI | Class I | Active |
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