Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Idylla™ Hub — IVDR Class A IVDR by Biocartis NV

MD Atlas
Biocartis NV

EUDAMED last updated this device on May 6, 2026

Idylla™ Hub

5415219P0010GM

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biocartis NV
UDI-DI code: 05415219001390
Reference / catalog number: P1030

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Biocartis NV
SRN: BE-MF-000003661
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW273
To avoid the risk of electrical shock, do not remove the outer cover of the Instrument or Hub. If the outer cover is damaged, do not use the System. To prevent the risk of electrical shock, keep the Instrument and Hub connectors away from liquids or moisture. Ensure an appropriate electrical supply. For safe operation, connect the device only to outlets with protective grounding with adequate current capacity. Verify that the electrical supply meets the required voltage. Ensure that the power outlets remain accessible at all times. Use the Instrument and Hub only with the supplied power cords. To prevent the risk of fire, keep flammable liquids away from electrical components.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Jan 1, 2027	Still on market

Device identification

Trade name: Idylla™ Hub
UDI-DI code: 05415219001390
Basic UDI-DI: 5415219P0010GM
Reference / catalog number: P1030
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Idylla™ Hub, which consists of software running on general‑purpose hardware components (a PC, a barcode scanner, and a Gateway), is a component of the Idylla™ Instrumentation. It enables bidirectional communication and centralized management of up to eight connected Idylla™ Instruments.
Additional information URL: https://www.biocartis.com/ifu
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02050116NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Idylla™ CDx MSI Test5415219A0220BVOn the market Idylla™ Console5415219P1010GUOn the market Idylla™ Console Software Plus (CSW+)5415219P2040HCOn the market Idylla™ EGFR Mutation Test5415219A0270CCOn the market Idylla™ Instrument5415219P0010GMOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.