Unip Plastic Industries Sdn Bhd
Malaysian manufacturer of plastic injection moulding, medical devices with clean room facilities,
Unip Plastic Industries Sdn Bhd manufactures plastic injection moulding, medical devices with clean room facilities, toothbrush & oral care in Balakong, Malaysia. The company was established in 1985 and supplies business customers in Malaysia and regional markets.
- Type
- Manufacturer
- Location
- Balakong, Malaysia
- Founded
- 1985
- Website
- unipberhad.com
- Categories
- Furniture, Medical & Healthcare Supplies
- Markets
- Malaysia, Singapore
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-10 Mail server of the company domain
- debarment-clear (green), checked 2026-08-10 OpenSanctions
- fda-registered (green), checked 2026-08-10 FDA
- fda-contract-manufacturer (green), checked 2026-08-10 FDA
- domain-registered (green), checked 2026-08-10 Domain registry record
- sanctions-clear (green), checked 2026-08-10 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management 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)
- Wood furniture imported into the EU falls under the Deforestation Regulation (EUDR): due-diligence statements with geolocation of origin. European Commission (EUDR)
- Consumer goods sold in the EU fall under the General Product Safety Regulation (GPSR, applies since 13 Dec 2024): a responsible person in the EU is mandatory. EUR-Lex: Regulation (EU) 2023/988 (GPSR)