Biocartis
Biocartis
Biocartis is an innovative molecular diagnostics company committed to revolutionize molecular testing with its unique proprietary IdyllaTM platform. We provide next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus on oncology.
- Type
- Distributor
- Location
- Belgium
- Website
- https://biocartis.com
- Categories
- Medical & Healthcare Supplies
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-05 Mail server of the company domain
- domain-registered (green), checked 2026-08-05 Domain registry record
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- sanctions-clear (green), checked 2026-08-05 OpenSanctions
- lei-lapsed (amber), checked 2026-08-05 GLEIF
- fda-registered (green), checked 2026-08-05 FDA
- debarment-clear (green), checked 2026-08-05 OpenSanctions
Claimed certifications
- 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)