STRAITS ORTHOPAEDICS (MFG) SDN BHD
Dental Supplies & Equipment, Malaysia
STRAITS ORTHOPAEDICS (MFG) SDN BHD is a dental supplies & equipment company based in Perai Pulau Pinang, Malaysia. Listed in a public business registry.
- Type
- Manufacturer
- Location
- Perai Pulau Pinang, Malaysia
- Categories
- 歯科用品および歯科用機器, 医療およびヘルスケア用品
Listed in a source registry
Verified facts
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- 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)