BioLineRx
Oncology and rare disease therapeutic products.
BioLineRx manufactures oncology and rare disease therapeutic products from its Modi’in operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Modi’in, Israel
- Founded
- 2003
- Website
- biolinerx.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Israel, United States, Germany, Japan
Verified facts
- domain-registered (green), checked 2026-08-05 Domain registry record
- sanctions-clear (green), checked 2026-08-05 OpenSanctions
- debarment-clear (green), checked 2026-08-05 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-05 Mail server of the company domain
- lei-lapsed (amber), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- Good Manufacturing Practice
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)