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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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ABX Lysebio 1L — 2 UDI-DI variants, IVDR (HORIBA ABX SAS)

MD Atlas
HORIBA ABX SAS

Data from EUDAMED, last updated May 19, 2026

ABX Lysebio 1L

361023lysebioQM

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: HORIBA ABX SAS

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 361023lysebioQM
Device name: ABX Lysebio 1L
Device model: 0906012
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Jun 14, 2023

Manufacturer & authorised representative

Manufacturer

Name: HORIBA ABX SAS
SRN: FR-MF-000000320
Country: France
Email: caroline.ferrer@horiba.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01H2WWZ8H2N87P89N8DPMMWZ3D

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

090601303610230004692
090601203610230004685