Supermax
Luvas de borracha e lentes de contato da Malásia.
A Supermax fabrica luvas descartáveis e expandiu-se para a fabricação de lentes de contato sob marcas da Malásia. A empresa fornece canais de distribuição médica, industrial e óptica em todo o mundo.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Sungai Buloh, Malaysia
- Founded
- 1987
- Website
- supermax.com.my
- Categories
- Suprimentos médicos e de saúde, Equipamentos de segurança e proteção, Óculos e óculos de sol, Borracha e materiais compostos
- Markets
- Malásia, Estados Unidos, Alemanha, Singapura
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
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 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-08-12 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
Claimed certifications, not confirmed by us
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
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)