Shanghai Heartcare Medical Technology Corporation Limited
Registered establishment in Shanghai, China. 2 device types, 3 clearances.
Shanghai Heartcare Medical Technology Corporation Limited is a manufacturer holding a current FDA establishment registration. The registration covers Catheter, Percutaneous, Catheter, Percutaneous, Neurovasculature. Its earliest product listing with the FDA dates from 2023.
2device types registered with the FDA
3510(k) clearances
Registration
| Registered name | SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CORPORATION LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3024801436 |
| FEI number | 3024801436 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海心瑋醫療科技股份有限公司 |
|---|---|
| Source | Hong Kong stock exchange filings |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Building 38, No.356 Zhengbo Road, LIN-GANG Special Area |
| Postal code | 201422 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Percutaneous | Class 2 | Distal Access Catheter, Micro Catheter, Balloon Guiding Catheter | 2023 | 14 |
| Catheter, Percutaneous, Neurovasculature | Class 2 | Distal Access Catheter, Micro Catheter, Balloon Guiding Catheter | 2023 | 6 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233205 | 2023-12-22 | QJP | Traditional | This company |
| K202926 | 2022-02-10 | QJP | Traditional | This company |
| K202916 | 2021-08-25 | QJP | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Employees | 327-368 |
| Main products | Thrombectomy stents, Microcatheters, Balloon catheters, Neuro-interventional devices, Stroke prevention devices |
| Certifications | National high-tech enterprise, National Specialized and New Small Giant, CNAS laboratory accreditation, FDA, MDR (EU) |
| Export markets | US, EU, Thailand, Ecuador, Taiwan |
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.
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