GREATCARE 4U SDN BHD
Dental Supplies & Equipment, Malaysia
GREATCARE 4U SDN BHD is a dental supplies & equipment company based in Selangor Darul Ehsan, Malaysia. Listed in a public business registry.
- Type
- Manufacturer
- Location
- Selangor Darul Ehsan, Malaysia
- Website
- https://www.greatcare4u.com
- Categories
- Perlengkapan & Peralatan Gigi, Perlengkapan Medis & Kesehatan
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)