Lepu Medical Technology (Beijing) Co., Ltd.
Empresa líder china en dispositivos cardiovasculares que produce stents, electrofisiología y diagnósticos POC.
Lepu Medical fabrica stents liberadores de fármacos coronarios, oclusores de FOP, dispositivos para el control del ritmo cardíaco y productos de diagnóstico en el lugar de atención que cubren troponina, BNP y HbA1c. Con marcas CE y autorizaciones de la FDA en todas sus familias de productos, la empresa exporta a más de 100 países y coopera con Boston Scientific en la distribución de cardiología intervencionista en China.
- Type
- brand seeking distribution
- Location
- Beijing, China
- Founded
- 1999
- Website
- lepumedical.com
- Categories
- Suministros médicos y sanitarios
- Markets
- China, Alemania, Estados Unidos, India, Brasil
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)