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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 3 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ALLEVYN Ag Small Sacrum | 66020983 | FDA UDI | U | Active |
| Renasys | 66020913 | FDA UDI | Class II | Active |
| Renasys Touch Device & Power Sup | 66801281 | FDA UDI | Class II | Active |
| REPLICaRE 1.5X2.5IN (4X6CM) | 483000 | FDA UDI | Class I | Active |
| VERSAJET III PRECISION Hydrosurgery System Hand Piece | 66802147 | FDA UDI | Class II | Active |
| Renasys | 66027660 | FDA UDI | Class II | Active |
| Allevyn Ag Sacrum Large Ctn10 | 66020984 | FDA UDI | U | Active |
| Exu-Dry Adult Buttock Pkg 10 | 5999BP1 | FDA UDI | Class I | Active |
| Renasys Edge | 66803126 | FDA UDI | Class II | Active |
| Acticoat Exfix Dressing Us Ctn Of 10 | 66800637 | FDA UDI | U | Active |
| Pico™ 7 | 66022014 | FDA UDI | Class II | Active |
| Renasys Edge | 66803141 | FDA UDI | Class II | Active |
| Acticoat Flex3 8" X 16" | 66800418 | FDA UDI | U | Active |
| Pico | 66800952 | FDA UDI | Class II | Active |
| Allevyn Sacrum Small 17x17cm Ctn 10 | 66000700 | FDA UDI | Class I | Active |
| Primapore Adhesive Wound Drsg 7.2*5cm | 7133 | FDA UDI | Class I | Active |
| ALLEVYN™ Ag+ | 66027665 | FDA UDI | U | Active |
| Pico™ 7 | 66022004 | FDA UDI | Class II | Active |
| Leaf™ | 66802063 | FDA UDI | Class I | Active |
| Opsite Incise 55x45cm Ctn 10 | 4989 | FDA UDI | Class I | Active |
| Opsite Post Op 20x10cm Ctn 20 | 66000713 | FDA UDI | Class I | Active |
| Renasys Go | 66021496 | FDA UDI | Class II | Active |
| Allevyn Life Xl 21x21 Ctn10 | 66801070 | FDA UDI | Class I | Active |
| Exu-Dry Lg Padded Hand Pk 20 | 5999LPG | FDA UDI | Class I | Active |
| DURAFIBER Ag 10x12cm | 66800571 | FDA UDI | U | Active |
| Versajet | 66800040 | FDA UDI | Class II | Active |
| Allevyn Gentle Border 10x20cm | 66800900 | FDA UDI | Class I | Active |
| Allevyn Life M 12.9x12.9 Ctn10 | 66801068 | FDA UDI | Class I | Active |
| Versajet | 66800041 | FDA UDI | Class II | Active |
| PROFORE KIT LF ANKLE CIRC 18-25CM Case 8 | 66000770 | FDA UDI | Class I | Active |
| Cuticerin 7.5x20cm Ctn 50 | 66045561 | FDA UDI | U | Active |
| ACTICOAT FLEX7 2" x 2" | 66800403 | FDA UDI | U | Active |
| Pico | 66021361 | FDA UDI | Class II | Active |
| Acticoat 7 4" X 5" | 20141 | FDA UDI | U | Active |
| Leukostrip™ | 66002881 | FDA UDI | Class I | Active |
| Renasys | 66021811 | FDA UDI | Class II | Unknown |
| Acticoat Flex7 2.5cmx60cm Ctn Of 5 | 66800545 | FDA UDI | U | Active |
| Allevyn Life Sacrum (large) Pack Of 10 | 66801307 | FDA UDI | Class I | Active |
| Pico™ 7 | 66022013 | FDA UDI | Class II | Active |
| Iv3000-1-Hand 7x9cm Ported-Carton | 4006 | FDA UDI | Class I | Active |
| REMOVE Adhesive Rem. 237ml CE Mark | 59403325 | FDA UDI | Class I | Active |
| Acticoat 16"x16" | 20401 | FDA UDI | U | Active |
| Renasys Edge | 66803140 | FDA UDI | Class II | Active |
| REPLICaRE 8X8IN (20X20CM) | 483300 | FDA UDI | Class I | Active |
| Exu Dry Dressing 10x15cm Case 12x10 | 5999004120 | FDA UDI | Class I | Active |
| Leukostrip™ | 66072955 | FDA UDI | Class I | Active |
| Acticoat Flex7 16" X 16" | 66800408 | FDA UDI | U | Active |
| Renasys Go | 66800061 | FDA UDI | Class II | Active |
| REPLICaRE ULTRa 10X10CM CTN 10 | 66000434 | FDA UDI | Class I | Active |
| Pico™ 7 | 66022010 | FDA UDI | Class II | 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