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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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Organization name
UDI-DI code
Reference / catalog number

PLAT-03-020700 — IVDD — General IVDD by GOODGUT, SLU

MD Atlas
GOODGUT, SLU

EUDAMED last updated this device on Aug 7, 2025

PLAT-03-020700

B-08437023437063

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GOODGUT, SLU
UDI-DI code: 08437023437063
Reference / catalog number: PLAT-03-020700

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Manufacturer information

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

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08437023437063
Basic UDI-DI: B-08437023437063
Reference / catalog number: PLAT-03-020700
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: The in vitro diagnostic medical devices developed by GoodGut are tests that base their diagnoses on the detection and quantification of specific microorganisms present in stool samples. The detection and quantification of the biomarkers is done by qPCR, and, in a second step, a diagnostic is performed through the application of an algorithm where the support of a web platform is required.GoodGut-Test is a web application that complements the RAID-CRC qPCR kit, RAID-Dx qPCR kit, and TestUrGut qPCR kit. The platform is a complement (accessory) of the specific product since without it the quantitative results derived from the multiplex qPCR assays run would not be translated into a diagnostic report. The software is not sold separately GoodGut-Test is an accessory regarding Article 2, Number 4 of IVDR. For professional use only.
Additional information URL: https://professionalarea.goodgut.eu/documentos/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02060292POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

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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.