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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 Pentra HDL Direct CP — 2 UDI-DI variants, IVDR (HORIBA ABX SAS)

MD Atlas
HORIBA ABX SAS

Data from EUDAMED, last updated May 23, 2026

ABX Pentra HDL Direct CP

361023pentra_hdl_directN8

2 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: HORIBA ABX SAS

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 361023pentra_hdl_directN8
Device name: ABX Pentra HDL Direct CP
Device model: A11A01636
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: May 22, 2026

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

basicUdiUlid01KS7T0D1KD2VWWK627ZEGF0YK

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

A11A0193403610230005743
A11A0163603610230004999