Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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.

ABX Alphalyse 0.4L — 3 UDI-DI variants, IVDR (HORIBA ABX SAS)

MD Atlas
HORIBA ABX SAS

Data from EUDAMED, last updated May 19, 2026

ABX Alphalyse 0.4L

361023lyseX2

3 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

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?

Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 361023lyseX2
Device name: ABX Alphalyse 0.4L
Device model: 0906004
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Apr 21, 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

3 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01GYHG7R86PY54CWM2SYW067YB

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

090600403610230004661
090601403610230004708
070201003610230004555