Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009972873

FEI Number

3009972873

Entity Name

BIOCARTIS NV

City/State/Country

Mechelen Antwerpen, BE

Establishment Address

Generaal De Wittelaan 11B, Mechelen Antwerpen 2800, BE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Biocartis NV (Owner Number: 10055159)

Owner / Operator Contact Address

Generaal De Wittelaan 11B, Mechelen, BE-VAN 2800, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211181

PMA Number

N/A

All Registered Proprietary Names

Idylla CDx MSI Test Idylla System (Idylla Instrument and Idylla Hub) Idylla System (Idylla Console and Idylla Instrument) SeptiCyte RAPID Idylla MSI Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SFL	Nucleic Acid Based Assay, Microsatellite Instability	Unknown	Class 3	N/A	2025-09-17
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2017-07-13
PRE	Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers	Microbiology	Class 2	866.3215	2024-12-18
PZJ	Lynch Syndrome Test System	Immunology	Class 2	864.1866	2023-03-29

Official Correspondent

Benjamin Crystal

US Agent Details

Benjamin Crystal Business: Biocartis US, Inc Email: bcrystal@biocartis.com Phone: (508) 8432809

Related Public Records

Same Entity

Biocartis NV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009972873. Last updated year: 2026. Please use registration number 3009972873 when referencing this establishment in official correspondence.