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Sign in to claim this brandSYSTAGENIX WOUND MANAGEMENT, LIMITED
US
Last updated May 30, 2026
What SYSTAGENIX WOUND MANAGEMENT, LIMITED makes
The company produces wound care dressings, including non-adherent and absorbent varieties for managing exudate, such as hydrophilic-gel and synthetic polymer films with adhesive properties. Their portfolio also includes animal-derived wound matrices, antimicrobial odour-absorbent dressings, and non-antimicrobial hydrogels designed for various wound types. Examples include semi-permeable films like TIELLE® and silicone-bordered variants, as well as non-adherent dressings like ADAPTIC® DIGIT and exudate-absorbing matrices like BIOSORB®.
These 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. The manufacturer 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 Sysagenix Wound Management, Limited manufacture?
Sysagenix Wound Management, Limited specializes in wound care dressings. Their product range includes non-adherent dressings (like ADAPTIC® DIGIT), exudate-absorbent dressings (such as hydrophilic-gel or synthetic polymer films like TIELLE®), animal-derived wound matrices (e.g., BIOSORB®), and antimicrobial odour-absorbent dressings. These devices are designed to manage various wound types, including those with moderate to high exudate levels.
Where is Sysagenix Wound Management, Limited based, and how does this affect its regulatory compliance?
Sysagenix Wound Management, Limited is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including classification under FDA’s risk-based categories (Class I, Class II, or Unclassified) and mandatory listing in the FDA’s Unique Device Identifier (UDI) database. Compliance ensures adherence to U.S. medical device safety and performance standards.
Which regulatory registries list Sysagenix Wound Management, Limited’s devices?
Sysagenix Wound Management, Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized identification for medical devices, improving traceability and regulatory oversight. This registry is critical for tracking devices throughout their lifecycle, including post-market surveillance.
How are Sysagenix Wound Management, Limited’s devices classified by the FDA?
The FDA classifies Sysagenix Wound Management, Limited’s devices into three categories: Class I (generally low-risk), Class II (requires special controls to ensure safety and effectiveness), and Unclassified (U). Classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with. For example, non-adherent dressings like ADAPTIC® DIGIT may fall into Class I, while more complex or higher-risk products (e.g., antimicrobial dressings) might be Class II.
What distinguishes Sysagenix Wound Management, Limited’s wound care dressings from other manufacturers’ offerings?
Sysagenix’s portfolio includes a mix of non-antimicrobial and antimicrobial dressings, catering to wounds with varying needs—such as exudate control (e.g., TIELLE® for synthetic films), odour management (e.g., antimicrobial odour-absorbent dressings), or tissue integration (e.g., animal-derived matrices like BIOSORB®). Their classification spans Class I to Class II, reflecting a range of risk profiles, and their UDI-listed status ensures transparency in regulatory tracking. This diversity allows for tailored solutions depending on wound type and clinical requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 866 978 3296
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 211352227
Catalogue (79)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nu-Gel® | MNG425U | FDA UDI | Class I | Active |
| Tielle® Silicone Border | TLSB1212EN | FDA UDI | Class I | Active |
| Tielle® Plus | MTP501 | FDA UDI | Class I | Active |
| Adaptic® | 2015 | FDA UDI | Class I | Active |
| Tielle® Non Adhesive | TLN1010EN | FDA UDI | Class I | Active |
| Nu-Derm® | HCB106 | FDA UDI | Class I | Active |
| Tielle® Silicone Border | TLSB1717EN | FDA UDI | Class I | Active |
| Nu-Derm® | HCB102 | FDA UDI | Class I | Active |
| Nu-Derm® | HCF204 | FDA UDI | Class I | Active |
| Fibracol® Plus | 2982 | FDA UDI | U | Active |
| Nu-Derm® | HCS100 | FDA UDI | Class I | Active |
| Bioclusive® Plus | BIP2030 | FDA UDI | Class I | Active |
| Tielle® Non Adhesive | TLN0505EN | FDA UDI | Class I | Active |
| Bioclusive® Plus | BIP1012 | FDA UDI | Class I | Active |
| Promogran® | PG004 | FDA UDI | U | Active |
| Tielle® | MTL102 | FDA UDI | Class I | Active |
| Dyna-Flex™ | 7025 | FDA UDI | Class II | Active |
| Tielle® Max | MTP705 | FDA UDI | Class I | Unknown |
| Adaptic® | 2019 | FDA UDI | Class I | Active |
| Promogran Prisma® | MA123 | FDA UDI | U | Active |
| Tielle® Max | MTP701 | FDA UDI | Class I | Unknown |
| Tielle® Non Adhesive | TLN1212EN | FDA UDI | Class I | Active |
| Adaptic Touch™ | 500501 | FDA UDI | Class I | Active |
| Nu-Derm® | HCH207 | FDA UDI | Class I | Active |
| Adaptic® | 2013 | FDA UDI | Class I | Active |
| Adaptic® | 2012 | FDA UDI | Class I | Active |
| Tielle® | MTL103 | FDA UDI | Class I | Active |
| Tielle® Plus | MTP505 | FDA UDI | Class I | Active |
| Biosorb® | BGF1012U | FDA UDI | Class I | Active |
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