Inzign
Medical device contract manufacturing and lab-on-chip production.
Inzign manufactures medical device components, lab-on-chip products and precision plastic parts in Singapore. The company provides contract manufacturing, tooling, injection moulding and assembly services for medtech customers.
- Type
- Manufacturer
- Location
- Singapore
- Founded
- 1981
- Website
- inzign.com
- Categories
- Medical & Healthcare Supplies, Packaging & Printing Supplies
- Markets
- Singapore, United States, Germany, Malaysia
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- domain-registered (green), checked 2026-08-08 Domain registry record
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management 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)
- If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)