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Sign in to claim this brandEXTREMITY CARE, LLC
US
Last updated May 31, 2026
What EXTREMITY CARE, LLC makes
Extremity Care, LLC produces single-use and reusable wound care products, including medicated wound dressing kits, tissue injection cannulas, and manual scalpel blades. Their portfolio also features synthetic and animal-derived wound matrix dressings, adhesive skin tapes for fixation, and semi-permeable film dressings. They supply syringe dispensing guns for precise medication delivery and offer adhesive-backed dressings designed for secure wound coverage.
The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Extremity Care, LLC operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices.
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 Extremity Care, LLC manufacture?
Extremity Care, LLC specializes in wound care products, including single-use and reusable items. Their portfolio covers medicated wound dressing kits, tissue injection cannulas, manual scalpel blades, and both synthetic and animal-derived wound matrix dressings. They also produce adhesive skin tapes for dressing fixation, semi-permeable film dressings, and syringe dispensing guns for medication delivery. These devices are designed to support wound management and healing.
Where is Extremity Care, LLC based, and what regulatory framework does it follow?
Extremity Care, LLC is based in the United States. Since their devices are marketed domestically, they must comply with U.S. regulatory requirements, including those set by the FDA. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify medical devices in the U.S. market.
Which regulatory registries or databases list devices manufactured by Extremity Care, LLC?
Devices from Extremity Care, LLC are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each medical device, ensuring traceability and transparency in the regulatory and clinical settings. This helps healthcare providers and regulators verify device details, including classification and compliance status.
How are Extremity Care, LLC’s devices classified under FDA regulations?
Extremity Care, LLC’s devices fall into different FDA classification categories: Class I (generally low-risk devices requiring minimal regulation), Class II (devices with moderate risk requiring special controls), and Unclassified (U) devices (those not yet assigned a risk class). The classification depends on factors like intended use, potential risks, and benefits, determining the regulatory pathway each device must follow for market authorization.
What is the significance of the FDA’s Unique Device Identifier (UDI) listing for Extremity Care, LLC’s products?
The FDA’s UDI database listing ensures that each of Extremity Care, LLC’s devices has a standardized, unique identifier linked to key product details like brand name, model, and lot number. This improves patient safety by reducing errors in device selection and tracking, aids in post-market surveillance, and supports compliance with FDA reporting requirements. It also helps healthcare providers quickly access critical information during clinical use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 555 E North Ln, Conshohocken, PA, 19428
- 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
- 3014269452
- DUNS Number
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Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| carePAC | CS-MA01 | FDA UDI | Class II | Active |
| carePAC | CS-PA01 | FDA UDI | Class II | Active |
| Extremity Care | ALC325 | FDA UDI | Class I | Active |
| carePAC | ECP-030 | FDA UDI | Class II | Active |
| Extremity Care | ATL100S | FDA UDI | Class I | Active |
| Extremity Care | ALC300S | FDA UDI | Class I | Active |
| Extremity Care | ALC225 | FDA UDI | Class I | Active |
| carePAC | ECD-030 | FDA UDI | Class II | Active |
| carePAC | CS-PN01 | FDA UDI | Class II | Active |
| careLAGEN | EC011 | FDA UDI | U | Active |
| Extremity Care | ATL400 | FDA UDI | Class I | Active |
| carePAC | CS-PB01 | FDA UDI | Class II | Active |
| Extremity Care | ALC425 | FDA UDI | Class I | Active |
| Extremity Care | ALC400S | FDA UDI | Class I | Active |
| Extremity Care | ALC100S | FDA UDI | Class I | Active |
| Kendall | EC007 | FDA UDI | Class I | Active |
| Extremity Care | ALC125 | FDA UDI | Class I | Active |
| careLAGEN | EC004 | FDA UDI | U | Active |
| careLAGEN | EC008 | FDA UDI | U | Active |
| Paper Surgical Tape | EC001 | FDA UDI | Class I | Active |
| carePAC | CX-MB01 | FDA UDI | Class II | Active |
| careGARD | EC002 | FDA UDI | Class I | Active |
| carePAC | ECA-030 | FDA UDI | Class II | Active |
| Extremity Care | ALC200S | FDA UDI | Class I | Active |
| carePAC | CX-PB01 | FDA UDI | Class II | Active |
| carePAC | CS-MN01 | FDA UDI | Class II | Active |
| carePAC | CS-MB01 | FDA UDI | Class II | Active |
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