PT. MEDISAFE TECHNOLOGIES
- Type
- brand seeking distribution
- Location
- Kab. Deli Serdang Sumatera Utara, Indonesia
- Categories
- Suministros médicos y sanitarios
Listed in a source registry
Verified facts
- certs-verified (green), checked 2026-08-19 Kemenkes e-Sertifikasi Alkes (Ministry of Health of Indonesia), medical-device certification lists
- registered-manufacturer (green), checked 2026-08-22 Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- fda-registered (green), checked 2026-09-02 FDA
- fda-contract-manufacturer (green), checked 2026-09-02 FDA
- debarment-clear (green), checked 2026-09-02 OpenSanctions
- sanctions-clear (green), checked 2026-09-02 OpenSanctions
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)