Data / Medical devices / Belgium / Biocartis NV

Biocartis NV: FDA-registered device maker in Mechelen Antwerpen, Belgium, 1 510(k) clearance and 1 PMA approval

Name: Biocartis NV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biocartis NV is registered with the FDA (registration 3009972873) in Mechelen Antwerpen, Belgium. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated August 15, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009972873
Address: Generaal De Wittelaan 11B, Mechelen Antwerpen, Belgium, 2800
Owner or operator: Biocartis NV (10055159)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed: July 13, 2017
Registered through: 2026
Brand names listed: Idylla MSI Test, Idylla CDx MSI Test, Idylla System (Idylla Console and Idylla Instrument), Idylla System (Idylla Instrument and Idylla Hub), SeptiCyte RAPID

Devices it lists

Device	Product code	Class	Role	Source
Lynch Syndrome Test System	PZJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Nucleic Acid Based Assay, Microsatellite Instability	SFL	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers	PRE	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 27, 2023	K211181	Idylla MSI Test	PZJ	Substantially Equivalent	Biocartis NV	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 15, 2025	P250005	Idylla CDx MSI Test	SFL	0	August 15, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 10, 2024	96022	Class II	Ongoing	Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.	False-positive MSI-H results generated by the Idylla MSI Test.	accessdata.fda.gov

Compare with other makers

Updated August 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.