Statistics for Biocartis NV

6Total Devices

5Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for Biocartis NV

No certificates registered for this manufacturer.

Showing 1–6 of 6 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Idylla™ CDx MSI Test	`A0220/6`	`15415219001328`	6	On the market
Idylla™ Console	`P1010`	`05415219000126`	1	On the market
Idylla™ Console Software Plus (CSW+)	`P2040`	`05415219001178`	1	On the market
Idylla™ EGFR Mutation Test	`A0270/6`	`05415219000843`	1	On the market
Idylla™ Hub	`P1030`	`05415219001390`	1	On the market
Idylla™ Instrument	`P0010`	`05415219000119`	1	On the market

Devices placed in 1 country

EUDAMED update: Apr 29, 2026

BE-MF-000003661

Active

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
SRN: BE-CA-007
Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

CASSIERS Annelies
Regulatory accountabilities addressing: - Technical documentation and EU Declaration of Conformity as per IVDR Art 15.3 (b). - QMS process related to IVDR Art 15.3 (c). - Reporting obligations as per IVDR Art 15.3 (c), Art 15.3 (d) Art 82 - 83, and Art 15.3 (e).
Hidden
CHATTERS Steve
QA accountabilities addressing: Conformity of devices before release as per IVDR Art. 15.3 (a). QMS processes related to IVDR Art 15.3 (a), Art 15.3 (d), and Art 82 - 84.
Hidden