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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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IDKhighX® stool preparation system — 3 UDI-DI variants, IVDR

MD Atlas
Immundiagnostik AG

Data from EUDAMED, last updated May 23, 2026

IDKhighX® stool preparation system

4050598IAhighXE2

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: Immundiagnostik AG

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Device characteristics

Self-testingProfessional testing

Identity & classification

Basic UDI-DI: 4050598IAhighXE2
Device name: IDKhighX® stool preparation system
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Mar 1, 2024

Manufacturer & authorised representative

Manufacturer

Name: Immundiagnostik AG
SRN: DE-MF-000020905
Country: Germany
Email: info@immundiagnostik.com
Phone: +496251701900

Variants by status

UDI-DI variants

3 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01HQX5R1Q27H66CV5AKCEZ9XFC

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

IDKhighX® stool preparaion system - prefilled Set04050598012073
IDKhighX® stool preparation system – empty04050598011830
IDKhighX® stool preparation system – prefilled04050598011915