K-One MediTech Sdn. Bhd
Fournitures et équipements dentaires, Malaisie
K-One MediTech Sdn. Bhd est une entreprise de Fournitures et équipements dentaires basée à Ipoh Perak, Malaisie. Inscrite dans un registre public des entreprises.
- Type
- Manufacturer
- Location
- Ipoh Perak, Malaysia
- Categories
- Fournitures et équipements dentaires, Fournitures médicales et de santé
Listed in a source registry
Verified facts
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
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)