Numen Helia 3D0104SS
by MicroPort NeuroTech (Shanghai) Co., Ltd.
Numen Helia 3D0104SS is a Class II device made by MicroPort NeuroTech (Shanghai) Co., Ltd., cleared under FDA 510(k) K260351 on 20 May 2026 and listed in FDA GUDID since 13 Jul 2026 (UDI-DI 06958698053379), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06958698053379 | Date13 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260351 | Date20 May 2026 | StatusActive |
Official records
- AccessGUDID record 06958698053379
- FDA 510(k) database K260351
Across registries
- FDA 510(k) K260351 decided 20 May 2026 Active
- FDA GUDID UDI-DI 06958698053379 listed 13 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K260351
- Listed FDA GUDID 06958698053379
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Numen Helia
- Generic name
- Neurovascular embolization coil
- Model / reference
- 3D0104SS
- Primary DI / UDI-DI
- 06958698053379
- 510(k) Number
- FDA product code
- HCG, KRD
- GMDN term
- Neurovascular embolization coil
- Device class
- Class II
- Regulation number
- 882.5950, 870.3300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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