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Sign in to claim this brandSmith & Nephew Medical, Ltd.
US
Last updated May 23, 2026
What Smith & Nephew Medical, Ltd. makes
The company manufactures wound care dressings, including non-antimicrobial and antimicrobial absorbent options, hydrophilic-gel exudate-absorbent dressings, adhesive bandages, and medicated wound dressing kits. It also produces negative-pressure wound therapy systems, both electric single-use and battery-powered reusable models, as well as water jet knife handpieces for surgical precision. Additional products include nonadherent wound dressings and specialized dressings like silver-impregnated antimicrobial variants.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under regulatory frameworks, with listings in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable domestic and international medical device regulations.
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 Smith & Nephew Medical, Ltd. primarily manufacture?
Smith & Nephew Medical, Ltd. specializes in wound care solutions, including a variety of dressings such as non-antimicrobial and antimicrobial exudate-absorbent options, hydrophilic-gel dressings, adhesive bandages, and medicated wound dressing kits. They also produce negative-pressure wound therapy systems—both electric single-use and battery-powered reusable models—as well as precision surgical tools like water jet knife handpieces. These devices are designed to address exudate management, wound healing, and surgical precision.
Where is Smith & Nephew Medical, Ltd. based, and how does this affect its regulatory compliance?
Smith & Nephew Medical, Ltd. is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. As a U.S.-based manufacturer, its products are subject to FDA oversight, including classification under Class I, Class II, or unclassified (U) categories, and mandatory listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and regulatory transparency.
Which regulatory registries or databases list Smith & Nephew Medical, Ltd.’s devices?
Smith & Nephew Medical, Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures standardized identification and tracking of medical devices, facilitating compliance, recall management, and post-market surveillance. The UDI system helps healthcare providers, regulators, and manufacturers maintain accurate records of device performance and safety.
How are Smith & Nephew Medical, Ltd.’s devices classified under regulatory frameworks?
Smith & Nephew Medical, Ltd.’s devices are classified under three regulatory categories: Class I (generally low-risk devices with minimal regulatory controls), Class II (moderate-risk devices requiring special controls to ensure safety and effectiveness), and unclassified (U) devices, which may require additional evaluation or fall into niche categories. Classification depends on factors like intended use, risk level, and potential impact on patient safety, as determined by regulatory bodies like the FDA.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (501)
Page 5 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Allevyn Ag Gntl Brder 17.5x17.5cm Us/Cn | 66800454 | FDA UDI | U | Active |
| Pico™ 7 | 66022018 | FDA UDI | Class II | Active |
| Acticoat Surgic 10x25cm 5pk Us | 66021772 | FDA UDI | U | Active |
| Cuticerin 10x10cm | 66045564 | FDA UDI | U | Active |
| Renasys | 66800394 | FDA UDI | Class II | Active |
| Pico™ 7 | 66002004 | FDA UDI | Class II | Active |
| Exu-Dry Drsg 3in Disc Pkg100 | 5999003 | FDA UDI | Class I | Active |
| ALLEVYN Gentle Border Sacrum | 66020413 | FDA UDI | Class I | Active |
| Biobrane | 66027706 | FDA UDI | U | Active |
| Opsite Post Op 10x35cm Ctn 20 | 66000716 | FDA UDI | Class I | Active |
| Renasys Edge | 66803142 | FDA UDI | Class II | Active |
| Opsite Incise 14x25cm Ctn 20 | 4967 | FDA UDI | Class I | Active |
| Allevyn Tracheostomy | 66027640, 66007640 | FDA UDI | Class I | Active |
| Exu-Dry Lg Boot/Foot Pk 20 | 5999FDL | FDA UDI | Class I | Active |
| Pico™ 7 | 66022008 | FDA UDI | Class II | Active |
| Renasys Touch | 66801278 | FDA UDI | Class II | Active |
| Renasys F Medium W/Soft Port | 66020795 | FDA UDI | Class II | Active |
| ALLEVYN Ag Adhesive 5in x 5in | 66020973 | FDA UDI | U | Active |
| Renasys Edge | 66803146 | FDA UDI | Class II | Active |
| Allevyn 2x2" USA Ctn 10 | 66027643, 66007643 | FDA UDI | Class I | Active |
| Allevyn Complete Care | 66807697 | FDA UDI | Class I | Active |
| No-Sting SKIN-PREP Wipes | 59420600 | FDA UDI | Class I | Active |
| Allevyn Life Non-Brdr 16x16cm Ctn10 | 66801749 | FDA UDI | Class I | Active |
| Spray-On SKIN-PREP 118ml Spray US | 420279 | FDA UDI | Class I | Active |
| Biobrane | 66027705 | FDA UDI | U | Active |
| Allevyn Ag Gentle Border 7.5x7.5cm | 66800452 | FDA UDI | U | Active |
| PROFORE LITE LF SYSTEM KIT Case 8 | 66000771 | FDA UDI | Class I | Active |
| Allevyn Heel 10.5cm X 13.5cm Ctn 5 | 66007630 | FDA UDI | Class I | Active |
| VERSAJET III Hydrosurgery System Console | 66802146 | FDA UDI | Class II | Active |
| Allevyn Life Non-Brdr 10.5x10.5cm | 66801748 | FDA UDI | Class I | Active |
| CONFORMANT 2 WND VL 15CM x 1.8M CS 20 | 5955602 | FDA UDI | Class I | Active |
| Opsite 28x10cm Us Ctn 10 | 4542 | FDA UDI | Class I | Active |
| Versajet | 66800474 | FDA UDI | Class II | Unknown |
| Renasys F Large W/Soft Port | 66020796 | FDA UDI | Class II | Active |
| Acticoat 4"x48" | 20501 | FDA UDI | U | Active |
| Algisite M 3/4x12" Ctn 10 | 59480400 | FDA UDI | Class I | Active |
| Exu-Dry Dressing 23x38cm Ctn 30 | 5999009 | FDA UDI | Class I | Active |
| Allevyn Ag Adhesive 7x7" Ctn10 | 66020976 | FDA UDI | U | Active |
| Acticoat 7 6" X 6" | 20241 | FDA UDI | U | Active |
| Opsite Flexigrid Usa 6x7cm-Carton Of 100 | 66024628 | FDA UDI | Class I | Active |
| Allevyn Gentle 15cm X 15cm Ctn 3 | 66802141 | FDA UDI | Class I | Active |
| Pico™ 7 | 66022005 | FDA UDI | Class II | Active |
| Leukostrip 6.4x76mm Ctn 50 | 66002878 | FDA UDI | Class I | Active |
| Renasys | 66021066 | FDA UDI | Class II | Active |
| Renasys Touch | 66801284 | FDA UDI | Class II | Active |
| Renasys | 66800193 | FDA UDI | Class II | Active |
| CUTICERIN 3X8IN PCH3 B25 Ca6 | 66045503 | FDA UDI | U | Active |
| Versajet | 66800042 | FDA UDI | Class II | Active |
| Pico 14 | 66022046 | FDA UDI | Class II | Active |
| Allevyn Gentle Border 10x30cm | 66800265 | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Smith & Nephew Medical, Ltd. has three recall records initiated between March 11, 2024, and October 2, 2024. The records include one classified and one open status. The reasons cited involve battery depletion and recharge failures due to improper battery maintenance, as well as black particulate matter from carbon filter components potentially damaging NPWT pumps.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 2, 2024 | Z-0516-2025 | — | open, classified | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| Mar 11, 2024 | Z-1596-2024 | — | open, classified | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| Mar 11, 2024 | Z-1597-2024 | — | open, classified | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Smith & Nephew Medical Ltd HULL East Riding of Yorkshire · GB FEI 3002808194