Supermax
Gummihandschuhe und Kontaktlinsen aus Malaysia.
Supermax stellt Einweghandschuhe her und hat sich auf die Herstellung von Kontaktlinsen unter malaysischen Marken ausgeweitet. Das Unternehmen beliefert weltweit medizinische, industrielle und optische Vertriebskanäle.
- Type
- brand seeking distribution
- Location
- Sungai Buloh, Malaysia
- Founded
- 1987
- Website
- supermax.com.my
- Categories
- Medizin- & Gesundheitsbedarf, Sicherheits- & Schutzausrüstung, Brillen & Sonnenbrillen, Gummi & Verbundwerkstoffe
- Markets
- Malaysia, Vereinigte Staaten, Deutschland, 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)