Supermax
Gants en caoutchouc et lentilles de contact de Malaisie.
Supermax fabrique des gants jetables et s'est développé dans la fabrication de lentilles de contact sous des marques malaisiennes. L'entreprise fournit des canaux de distribution médicaux, industriels et optiques dans le monde entier.
- Type
- brand seeking distribution
- Location
- Sungai Buloh, Malaysia
- Founded
- 1987
- Website
- supermax.com.my
- Categories
- Fournitures médicales et de santé, Équipements de sécurité et de protection, Lunetterie et lunettes de soleil, Caoutchouc et matériaux composites
- Markets
- Malaisie, États-Unis, Allemagne, Singapour
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)