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Organization name
UDI-DI code
Reference / catalog number

DX-02-2024-01-HP — IVDD — General IVDD by GOODGUT, SLU

MD Atlas
GOODGUT, SLU

EUDAMED last updated this device on Jul 1, 2025

DX-02-2024-01-HP

B-08437023437049

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GOODGUT, SLU
UDI-DI code: 08437023437049
Reference / catalog number: DX-02-2024-01-HP

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Manufacturer information

Organization name: GOODGUT, SLU
SRN: ES-MF-000000229
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Mar 1, 2019	Dec 31, 2023

Device identification

Trade name: not provided
UDI-DI code: 08437023437049
Basic UDI-DI: B-08437023437049
Reference / catalog number: DX-02-2024-01-HP
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Intender User. Professional User only. The RAID-Dx qPCR Kit is intended for diagnosing irritable bowel syndrome and performing its differential diagnosis from inflammatory bowel disease, through the detection of specific microbial markers in DNA samples extracted from patients’ faeces. The in vitro RAID-Dx qPCR Kit diagnostic test is based on the qPCR analysis of a panel of faecal microorganisms that are indicators of both favourable and unfavourable intestinal health conditions. The panel is made up of 9 biomarkers representing different species, phylogroups, genera, and other taxa: Faecalibacterium prausnitzii, F. prausnitzii phylogroup I and F. prausnitzii phylogroup II, Escherichia coli, Akkermansia muciniphila, Ruminococcus sp., Methanobrevibacter smithii, Bacteroidetes, and Eubacteria. The qPCR Kit allows the amplification and quantification of characteristic gene fragments of the mentioned microorganisms. Results are given in a report both qualitatively and quantitatively.
Additional information URL: https://professionalarea.goodgut.eu/documentos/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101060399FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER

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Sterile

Single use

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New device

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