Kossan Rubber Industries
Guantes, productos técnicos de caucho y productos para salas blancas.
Kossan Rubber Industries fabrica guantes médicos, guantes industriales, productos técnicos de caucho y productos para salas blancas en Malasia. Sus productos sirven a clientes de atención médica, infraestructura, automoción e industria.
- Type
- brand seeking distribution
- Location
- Klang, Malaysia
- Founded
- 1979
- Website
- kossan.com.my
- Categories
- Suministros médicos y sanitarios, Equipos de seguridad y protección, Suministros industriales, Caucho y materiales compuestos
- Markets
- Malasia, Estados Unidos, Alemania, Singapur
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- debarment-clear (green), checked 2026-08-06 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- FDA Registered FDA Establishment Registration
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
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)