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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

CRC-01-2250-01 — IVDD — General IVDD by GOODGUT, SLU

MD Atlas
GOODGUT, SLU

EUDAMED last updated this device on Jul 1, 2025

CRC-01-2250-01

B-08437023437025

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GOODGUT, SLU
UDI-DI code: 08437023437025
Reference / catalog number: CRC-01-2250-01

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Manufacturer information

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

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Follow the basic instructions of a laboratory that performs qPCR testing and biological analysis

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jan 17, 2020	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 08437023437025
Basic UDI-DI: B-08437023437025
Reference / catalog number: CRC-01-2250-01
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 RAID-CRC Symptomatic qPCR Kit is intended for the screening of advanced colorectal neoplasia in symptomatic patients who obtain a positive result in the faecal immunochemical test (FIT), through the detection of specific bacterial markers in DNA samples extracted from patients’ faeces. The RAID-CRC Symptomatic qPCR Kit in vitro diagnostic test is based on the qPCR analysis of a panel of faecal bacteria indicative of both favourable and unfavourable conditions of intestinal health. The panel is used in symptomatic individuals as a screening step to rule out colorectal cancer. The RAID-CRC Symptomatic qPCR Kit is based on proprietary technology that detects a combination of 4 bacterial markers tested in faecal samples: Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus stomatis, and Eubacteria. The qPCR kit allows amplifying and quantifying the characteristic gene fragments of the mentioned microorganisms. Results are provided in qualitative and quantitative form. The product is not automatic. The intended user is a laboratory professional.
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

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.