Supermax
来自马来西亚的橡胶手套和隐形眼镜。
Supermax 生产一次性手套，并已扩展到马来西亚品牌的隐形眼镜制造领域。该公司在全球范围内提供医疗、工业和光学分销渠道。
- 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
- 医疗保健用品, 安全及防护设备, 眼镜和太阳镜, 橡胶及复合材料产品
- Markets
- 马来西亚, 美国, 德国, 新加坡
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)