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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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Idylla™ Instrument — 2 UDI-DI variants, IVDR (Biocartis NV)

MD Atlas
Biocartis NV

Data from EUDAMED, last updated May 23, 2026

Idylla™ Instrument

5415219P0010GM

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: Biocartis NV

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 5415219P0010GM
Device name: Idylla™ Instrument
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Jun 29, 2022

Manufacturer & authorised representative

Manufacturer

Name: Biocartis NV
SRN: BE-MF-000003661
Country: Belgium
Email: regulatory@biocartis.com
Phone: +32 15 632 600

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01G6PZQ4YDDD4YBE9WGDKQZQC3

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Idylla™ Hub05415219001390
Idylla™ Instrument05415219000119