K-One MediTech Sdn. Bhd
Dental Supplies & Equipment, Malaysia
K-One MediTech Sdn. Bhd is a dental supplies & equipment company based in Ipoh Perak, Malaysia. Listed in a public business registry.
- Type
- Manufacturer
- Location
- Ipoh Perak, Malaysia
- Categories
- दंत चिकित्सा आपूर्ति एवं उपकरण, चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
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)