Manufacturer and brand owner in Beijing, China. 7 device types, 7 products catalogued, 7 clearances.
Lepu Medical Technology (Beijing) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Clamp, Vascular, Introducer, Catheter and 5 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
FDA registration record for Lepu Medical Technology (Beijing) Co., Ltd. | Registered name | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008002401 |
| FEI number | 3008002401 |
| DUNS | 529853921 |
| Establishment type | Manufacturer |
Location
Address of Lepu Medical Technology (Beijing) Co., Ltd. | City | Beijing |
| Province | Beijing |
| Address | No.37 Chaoqian Rd. |
| Postal code | 102200 |
| Country | China |
Group
Lepu Medical Technology (Beijing) Co., Ltd. is one of 2 plants registered under Lepu Medical Technology (Beijing) Co., Ltd.
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Lepu Medical Technology (Beijing) Co., Ltd. | Founded | 1999 |
| Main products | Coronary stents, Drug-eluting stents, Cardiac pacemakers, AI-ECG systems, Interventional cardiology devices |
| Certifications | FDA, CE |
| Export markets | 160+ countries and regions; operations in US, Netherlands, Germany, Brazil, India, Indonesia, Malaysia |
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.