Identity
- Trade Name
- OviTex® 2S FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
- Device Name
- The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction. FDA UDI
- Model / Reference
- F10248-1012P EUDAMEDFDA UDI
- Description
- The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421904065161 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09421904065161 EUDAMED
- 510(k) Number
- K153632 FDA UDI
- FDA Product Code
- FTL FDA UDIFTM FDA UDI
- EMDN Code
- P900299 SURGICAL MESHES - OTHER EUDAMED
- GMDN Term
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
F10248-1012p by Aroa Biosurgery Ltd. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09421904065161 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Aroa Biosurgery Ltd.
- EUDAMED SRN
- NZ-MF-000003726
- Authorised Representative
- S4M EUROPE FR-AR-000000180
Sources (2)
- EUDAMED 2a0abe4e-06d3-4c47-acdc-5737b268357a 61 fields · synced Jun 20, 2026
- FDA UDI 17c50bb8-61f2-49eb-a60f-d64fe1e04935 36 fields · synced May 30, 2026