Identity
- Trade Name
- Oxiplex/SP Gel EUDAMED
- Device Name
- Oxiplex/SP Gel EUDAMED
- Model / Reference
- SPG03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705034342481 EUDAMED
- Basic UDI-DI
- B-10705034342481 EUDAMED
- EMDN Code
- M0406 DRESSINGS FOR THE PREVENTION OF POST-OPERATIVE ADHESIONS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oxiplex/SP Gel by FzioMed, Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253326 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | DEN240038 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-10705034342481 | Class III | Active |
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Manufacturer
- Manufacturer
- FzioMed, Inc.
- EUDAMED SRN
- US-MF-000003603
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 9ab04bfa-06e9-4f10-a8ff-daa136669e99 61 fields · synced Jul 9, 2026
- FDA 510(k) K253326 1 fields · synced May 18, 2026