Enlight Medical Technologies (Shenzhen) Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 1 device type, 2 products catalogued, 1 clearance.
Enlight Medical Technologies (Shenzhen) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Guide, Wire, Catheter, Neurovasculature. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
1device type
2products catalogued under its own name
1510(k) clearance
Registration
| Registered name | ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3034543750 |
| FEI number | 3034543750 |
| DUNS | 545380342 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 5-6/F, Building A, Xinghui Technology Industrial Park, 52 Huaning Road, Xinshi Community, Dalang Street |
| Postal code | 518109 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Guide, Wire, Catheter, Neurovasculature | Class 2 | Synxess Neurovascular Guidewire, Synxess, WaveSelect Neurovascular Guidewire | 2024 | 5 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| WaveSelect | MOF | 2 |
| Synxess | MOF | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240871 | 2024-11-18 | MOF | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2020 |
|---|---|
| Main products | Transcatheter mitral valve repair devices, Thoracic endovascular stent grafts, Peripheral stents, Deep brain stimulation devices, Spinal cord stimulation devices |
| Certifications | GMP standards |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.