PINTARMAS SDN BHD
Vật tư và thiết bị nha khoa, Malaysia
PINTARMAS SDN BHD là công ty trong lĩnh vực Vật tư và thiết bị nha khoa tại Johor Bahru, Malaysia. Được đăng ký trong cơ quan đăng ký doanh nghiệp công.
- Type
- Manufacturer
- Location
- Johor Bahru, Malaysia
- Categories
- Vật tư và thiết bị nha khoa
Listed in a source registry
Verified facts
- market-access-us (green), checked 2026-08-23 FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
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)