Data / Medical devices / China / Microport Neurotech (shanghai) Co., Ltd.
Microport Neurotech (shanghai) Co., Ltd.: FDA-registered device maker in Shanghai, China, 4 510(k) clearances
Microport Neurotech (shanghai) Co., Ltd. is registered with the FDA (registration 3016609702) in Shanghai, China. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016609702
- Address
- Building #16, 222 Guangdan Road, Pudong New District, Shanghai, China, 201318
- Owner or operator
- MicroPort NeuroTech (Shanghai) Co., Ltd. (10082955)
- Roles
- Manufacturer
- First device listed
- February 9, 2022
- Registered through
- 2026
- Brand names listed
- Numen Coil Embolization System; NumenFR Detachment System, Numen Helia Coil Embolization System; NumenFR Detachment System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 20, 2026 | K260351 | Numen Helia Coil Embolization System; NumenFR Detachment System | HCG | Substantially Equivalent | MicroPort NeuroTech (Shanghai) Co., Ltd. | accessdata.fda.gov |
| September 30, 2024 | K242154 | Numen Coil Embolization System; NumenFR Detachment System | HCG | Substantially Equivalent | MicroPort NeuroTech (Shanghai) Co., Ltd. | accessdata.fda.gov |
| January 10, 2024 | K232955 | Numen Coil Embolization System; NumenFR Detachment System | HCG | Substantially Equivalent | MicroPort NeuroTech (Shanghai) Co., Ltd. | accessdata.fda.gov |
| September 1, 2021 | K203625 | Numen Coil Embolization System; NumenFR Detachment System | HCG | Substantially Equivalent | MicroPort NeuroTech (Shanghai) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Neurovascular Embolization
- All makers of Device, Vascular, For Promoting Embolization
Updated May 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.