Supermax
Guantes de goma y lentes de contacto de Malasia.
Supermax fabrica guantes desechables y se ha expandido a la fabricación de lentes de contacto con marcas malayas. La empresa suministra canales de distribución médicos, industriales y ópticos en todo el mundo.
- Type
- brand seeking distribution
- Location
- Sungai Buloh, Malaysia
- Founded
- 1987
- Website
- supermax.com.my
- Categories
- Suministros médicos y sanitarios, Equipos de seguridad y protección, Gafas y gafas de sol, Caucho y materiales compuestos
- Markets
- Malasia, Estados Unidos, Alemania, Singapur
Verified facts
- certificate-page-on-site (amber), checked 2026-08-12 Company's own certification page
- fda-registered (green), checked 2026-08-12 FDA
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- 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)
- Protective equipment (helmets, gloves, eyewear) sold in the EU falls under the PPE Regulation (EU) 2016/425 and needs CE marking. European Commission (PPE)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)