PT PHILIPS INDUSTRIES BATAM
- Type
- brand seeking distribution
- Location
- Muka Kuning, Batam Riau, Indonesia
- Categories
- Fournitures et équipements dentaires, Fournitures médicales et de santé
Listed in a source registry
Verified facts
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- 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
- sanctions-clear (green), checked 2026-09-02 OpenSanctions
- debarment-clear (green), checked 2026-09-02 OpenSanctions
Claimed certifications
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
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)