Lepu Medical Technology (Beijing) Co., Ltd.
Leading Chinese cardiovascular-device company producing stents, electrophysiology, and POC diagnostics.
Lepu Medical makes coronary drug-eluting stents, PFO occluders, cardiac-rhythm management devices, and point-of-care diagnostic products covering troponin, BNP, and HbA1c. With CE marks and FDA clearances across its product families, the company exports to over 100 countries and co-operates with Boston Scientific on interventional cardiology distribution in China.
- Type
- Manufacturer
- Location
- Beijing, China
- Founded
- 1999
- Website
- lepumedical.com
- Categories
- Medical & Healthcare Supplies
- Markets
- China, Germany, United States, India, Brazil
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- lei-lapsed (amber), checked 2026-08-09 GLEIF
- fda-registered (green), checked 2026-08-09 FDA
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)