Identity
- Trade Name
- NEOVEIL EUDAMED
- Device Name
- NEOVEIL EUDAMED
- Model / Reference
- NV-ET-M30A-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04548366322603 EUDAMED
- Basic UDI-DI
- B-04548366322603 EUDAMED
- EMDN Code
- P900201 POLYGLYCOLIC ACID AND ASSOCIATIONS MESHES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain 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
Neoveil by Gunze Limited — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130997 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04548366322603 | Class III | Active |
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Manufacturer
- Manufacturer
- Gunze Limited
- EUDAMED SRN
- JP-MF-000015551
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c3bbeb50-f94d-4dd2-82d0-e3245588a8b8 85 fields · synced Jun 18, 2026
- FDA 510(k) K130997 1 fields · synced May 18, 2026