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Sign in to claim this brandGuard Medical, Inc.
US
Last updated May 30, 2026
What Guard Medical, Inc. makes
Guard Medical, Inc. manufactures negative-pressure wound therapy (NPWT) systems, specifically foam dressings designed for non-antimicrobial wound care. Their primary product, NPseal, is used to promote wound healing through controlled suction therapy.
The NPseal foam dressings are classified as Class II medical devices in the US and are authorised via 510(k) clearance and listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in 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 Guard Medical, Inc. manufacture?
Guard Medical, Inc. specializes in negative-pressure wound therapy (NPWT) systems, specifically foam dressings that are non-antimicrobial. Their primary product, NPseal, is designed to aid wound healing by applying controlled suction therapy to the affected area. These devices are tailored for use in clinical settings where wound care is critical.
Where is Guard Medical, Inc. based?
Guard Medical, Inc. is headquartered in the United States. The company’s focus on developing and manufacturing NPWT foam dressings is centered around this location, ensuring compliance with US regulatory standards.
Which regulatory registries or databases list Guard Medical, Inc.’s devices?
Guard Medical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. Additionally, their NPseal foam dressings are authorised through 510(k) clearance, which is a premarket submission process for Class II medical devices in the US. This ensures their products meet regulatory requirements before entering the market.
How are Guard Medical, Inc.’s devices classified in the US?
Guard Medical, Inc.’s foam dressings for negative-pressure wound therapy, such as NPseal, are classified as Class II medical devices in the US. Class II devices are generally considered to have an acceptable level of risk and require special controls in addition to general controls to ensure their safety and effectiveness. This classification applies to their primary product line.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- guard-medical.com
- —
- —
- [email protected]
- Phone
- 8884173644
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 118095992
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NPseal | GM01-005 | FDA UDI | Class II | Active |
| NPseal | GM01-001 | FDA UDI | Class II | Active |
| NPseal | GM01-003 | FDA UDI | Class II | Active |
| NPseal | GM01-002 | FDA UDI | Class II | Active |
| NPseal | GM01-004 | FDA UDI | Class II | Active |
| NPseal | K200305 | FDA 510(k) | Class II | Active |
| NPseal (20 and 25) | K241522 | FDA 510(k) | Class II | Active |
| NPseal | K250708 | FDA 510(k) | Class II | Active |
| NPseal | K212971 | FDA 510(k) | Class II | Active |
| NPseal | K251156 | FDA 510(k) | Class II | Active |
| NPseal | K211130 | FDA 510(k) | Class II | Active |
| NPseal (Small, Medium, Large) | K240244 | FDA 510(k) | Class II | Active |
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