Karex
Dispositivos médicos, suministros sanitarios y productos clínicos.
Karex fabrica dispositivos médicos, suministros sanitarios y productos clínicos en sus operaciones de Port Klang. La empresa abastece a compradores de hospitales, distribuidores clínicos, sistemas de salud o clientes de exportación en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Port Klang, Malaysia
- Founded
- 1988
- Website
- karex.com.my
- Categories
- Suministros médicos y sanitarios, Suministros industriales
- Markets
- Malasia, Estados Unidos, Reino Unido, Japón
Verified facts
- web-presence-since (green), checked 2026-08-04 Internet Archive (Wayback)
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- fda-registered (green), checked 2026-08-08 FDA
- debarment-clear (green), checked 2026-08-08 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- 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)