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Sign in to claim this brandPensar Medical, LLC
US
Last updated May 23, 2026
What Pensar Medical, LLC makes
Pensar Medical produces single-use and reusable components for negative-pressure wound therapy (NPWT), including electric systems, canisters, dressing sets, foam dressings (both antimicrobial and non-antimicrobial), tubing sets, connectors, drapes, and carrying cases. These products are designed to manage wound healing through controlled suction therapy, with variations in size and functionality to accommodate different clinical needs.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The portfolio is regulated in the United States, where Pensar Medical is based.
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 Pensar Medical, LLC manufacture?
Pensar Medical, LLC specializes in components and systems for negative-pressure wound therapy (NPWT). Their portfolio includes single-use and reusable items like electric NPWT systems, canisters for fluid collection, dressing sets, foam dressings (both antimicrobial and non-antimicrobial), tubing sets, connectors, drapes, and carrying cases. These devices are designed to promote wound healing by applying controlled suction therapy, with variations tailored to different clinical applications.
Where is Pensar Medical, LLC based, and where are their devices regulated?
Pensar Medical, LLC is based in the United States. Their devices are regulated under U.S. FDA guidelines, specifically as Class II medical devices, which require premarket notification (510(k)) clearance before commercial distribution. This classification applies to their NPWT-related products, ensuring they meet regulatory standards for safety and performance.
Which regulatory databases list Pensar Medical’s devices?
Pensar Medical’s devices are included in the FDA’s 510(k) database, which tracks premarket submissions for Class II medical devices, and the Unique Device Identifier (UDI) database. These registries help track device authorization status, manufacturing details, and compliance with U.S. regulatory requirements for their NPWT systems and components.
How are Pensar Medical’s devices classified under FDA regulations?
Pensar Medical’s devices fall under FDA’s Class II classification, which applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification is common for NPWT systems and accessories, as they involve controlled suction therapy for wound management, necessitating validation of performance and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 079262228
Catalogue (77)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| WoundPro Collection Canister | 8463540 0222 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5007 | FDA UDI | Class II | Active |
| Advanced Series Combo Pack, Small | 8463540 0731-CA | FDA UDI | Class II | Active |
| WoundPro Basic Series Y-Connector | 8463540 0674 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4002 | FDA UDI | Class II | Active |
| WoundPro Uniflo Advanced Y Connector | 8463540 0846 | FDA UDI | Class II | Active |
| 300cc Advanced Canister w/8' Tubing | 8463540 0735 | FDA UDI | Class II | Active |
| WoundPro Carrying Case | 8463540 0261 | FDA UDI | Class II | Active |
| Basic Series Hydrophobic Dressing Kit, Small | 8463540 0584 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5006 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5011 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5016 | FDA UDI | Class II | Active |
| WoundPro Control Unit | 8463540 0181 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4014 | FDA UDI | Class II | Active |
| Basic Series Hydrophobic Dressing Kit, Small | 8463540 0583 | FDA UDI | Class II | Active |
| ProFoam Bridge Dressing | 8463540 0621 | FDA UDI | Class II | Active |
| Silver ProFoam Hydrophobic Dressing, Small | 8463540 0597 | FDA UDI | Class II | Active |
| Silver ProFoam Hydrophobic Dressing, Large | 8463540 0601 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4004 | FDA UDI | Class II | Active |
| Advanced Series Hydrophobic Dressing Kit, Small | 8463540 0731 | FDA UDI | Class II | Active |
| WoundPro Outer Drape | 8463540 0639 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5014 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4013 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4011 | FDA UDI | Class II | Active |
| WoundPro+ 300cc Advanced Canister w/8' Tubing | 8463540 0946 | FDA UDI | Class II | Active |
| Advanced Series Y-Connector | 8463540 0756 | FDA UDI | Class II | Active |
| MicroDoc NPWT Control Unit | 8463550 1003 | FDA UDI | Class II | Active |
| Advanced Series Combo Pack, Large | 8463540 0733-CA | FDA UDI | Class II | Active |
| WoundPro Power Supply Cord | 8463540 0194 | FDA UDI | Class II | Active |
| WoundPro+ Collection Canister | 8463540 0921 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4006 | FDA UDI | Class II | Active |
| Basic Series Combo Pack, Small | 8463540 0583-CB | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5017 | FDA UDI | Class II | Active |
| Advanced Series Hydrophobic Dressing Kit, Large | 8463540 0733 | FDA UDI | Class II | Active |
| Basic Series Hydrophobic Dressing Kit, Large | 8463540 0585 | FDA UDI | Class II | Active |
| Silver ProFoam Hydrophobic Dressing, Medium | 8463540 0599 | FDA UDI | Class II | Active |
| MicroDoc NPWT Control Unit | 8463550 1002 | FDA UDI | Class II | Active |
| Advanced Series StingRay Suction Bell | 8463540 0720 | FDA UDI | Class II | Active |
| Hydrophilic Foam Dressing, Medium | 8463540 0611 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 5004 | FDA UDI | Class II | Active |
| Basic Series StingRay Suction Bell | 8463540 0636 | FDA UDI | Class II | Active |
| 800cc Advanced Canister w/5' Tubing | 8463540 0736 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4003 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4016 | FDA UDI | Class II | Active |
| WoundPro Hydrophobic Foam Dressing, Medium | 8463540 0578 | FDA UDI | Class II | Active |
| WoundPro Hydrophobic Foam Dressing, Large | 8463540 0579 | FDA UDI | Class II | Active |
| Basic Series Combo Pack, Large | 8463540 0585-CB | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4001 | FDA UDI | Class II | Active |
| WoundPro+ 300cc Advanced Canister w/5' Tubing | 8463540 0916 | FDA UDI | Class II | Active |
| MicroDoc NPWT System | 8463550 4005 | FDA UDI | Class II | Active |
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