Lepu Medical Technology (Beijing) Co., Ltd.
Empresa chinesa líder em dispositivos cardiovasculares que produz stents, eletrofisiologia e diagnóstico POC.
A Lepu Medical fabrica stents farmacológicos coronários, oclusores de PFO, dispositivos de gerenciamento de ritmo cardíaco e produtos de diagnóstico no local de atendimento que abrangem troponina, BNP e HbA1c. Com marcas CE e autorizações da FDA em todas as suas famílias de produtos, a empresa exporta para mais de 100 países e coopera com a Boston Scientific na distribuição de cardiologia intervencionista na China.
- Type
- Manufacturer
- Location
- Beijing, China
- Founded
- 1999
- Website
- lepumedical.com
- Categories
- Suprimentos médicos e de saúde
- Markets
- China, Alemanha, Estados Unidos, Índia, Brasil
Verified facts
- 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
- facility-registered (green), checked 2026-08-03 US FDA device establishment registration (openFDA)
- domain-registered (green), checked 2026-08-09 Domain registry record
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)