GREATCARE 4U SDN BHD
Vật tư và thiết bị nha khoa, Malaysia
GREATCARE 4U SDN BHD là công ty trong lĩnh vực Vật tư và thiết bị nha khoa tại Selangor Darul Ehsan, Malaysia. Được đăng ký trong cơ quan đăng ký doanh nghiệp công.
- Type
- Manufacturer
- Location
- Selangor Darul Ehsan, Malaysia
- Website
- https://www.greatcare4u.com
- Categories
- Vật tư và thiết bị nha khoa, Vật tư y tế và chăm sóc sức khỏe
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-08-14 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-14 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-14 OpenSanctions
- fda-registered (green), checked 2026-08-14 FDA
- fda-contract-manufacturer (green), checked 2026-08-14 FDA
- domain-registered (green), checked 2026-08-14 Domain registry record
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
Claimed certifications
- FDA Registered FDA Establishment Registration
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)