PINTARMAS SDN BHD
Dentalbedarf & -geräte, Malaysia
PINTARMAS SDN BHD ist ein Unternehmen im Bereich Dentalbedarf & -geräte mit Sitz in Johor Bahru, Malaysia. Eingetragen in einem öffentlichen Unternehmensregister.
- Type
- Manufacturer
- Location
- Johor Bahru, Malaysia
- Categories
- Dentalbedarf & -geräte
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)