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Sign in to claim this brandTissue Regenix Wound Care Inc.
US
Last updated May 26, 2026
What Tissue Regenix Wound Care Inc. makes
Tissue Regenix Wound Care Inc. manufactures bioabsorbable collagen-based surgical mesh designed for extra-gynaecological applications. The product line includes SurgiPure® XD, a non-antimicrobial mesh intended for tissue integration and wound support.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
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 Tissue Regenix Wound Care Inc. manufacture?
Tissue Regenix Wound Care Inc. specializes in bioabsorbable surgical mesh made from collagen. These devices are designed for extra-gynaecological surgical applications, meaning they are used in areas outside the female reproductive system. The primary product, SurgiPure® XD, is intended to support tissue integration and wound healing without antimicrobial properties.
Where is Tissue Regenix Wound Care Inc. based?
The company is headquartered in the United States. This location influences its regulatory compliance and reporting requirements, particularly for devices marketed in the US market.
Which regulatory registries or databases list Tissue Regenix Wound Care Inc.’s devices?
Tissue Regenix Wound Care Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices through standardized identification codes, ensuring traceability and compliance with regulatory requirements.
How are Tissue Regenix Wound Care Inc.’s devices classified under medical device regulations?
The company’s devices fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as surgical meshes used for tissue integration.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- tissueregenix.com
- —
- —
- [email protected]
- Phone
- 1-855-452-0133
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 031826073
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SurgiPure® XD | 102015XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 050515XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 254015XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 202015XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 152515XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 101015XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 071015XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 101515XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 020515XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 152015XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 204015XD | FDA UDI | Class II | Active |
| SurgiPure® XD | 203015XD | FDA UDI | Class II | Active |
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