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

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Organization name
UDI-DI code
Reference / catalog number

Idylla™ Instrument — IVDR Class A IVDR by Biocartis NV

MD Atlas
Biocartis NV

EUDAMED last updated this device on Jun 29, 2022

Idylla™ Instrument

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: 05415219000119
Reference / catalog number: P0010

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Manufacturer information

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

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: Idylla™ Instrument
UDI-DI code: 05415219000119
Basic UDI-DI: 5415219P0010GM
Reference / catalog number: P0010
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: The Idylla™ System is an in vitro diagnostic (IVD) medical device, consisting of the Idylla™ Console and the Idylla™ Instrument(s). The System is intended for the detection of nucleic acid targets in various types of human samples, using disposable Test specific Idylla™ cartridges. Idylla™ covers the entire process from sample to result, including for example liquefaction, cell lysis, DNA/RNA extraction, real-time amplification/detection, and data analysis and reporting.
Additional information URL: No additional information URL provided by the manufacturer.
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

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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.