Biosensors International
Drug-eluting stents and interventional cardiology devices.
Biosensors International manufactures drug-eluting stents and interventional cardiology devices from its Singapore operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Singapore
- Founded
- 1990
- Website
- biosensors.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Singapore, United States, Germany, Japan
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- domain-registered (green), checked 2026-08-06 Domain registry record
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- debarment-clear (green), checked 2026-08-06 OpenSanctions
- web-presence-since (green), checked 2026-08-06 Internet Archive (Wayback)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)