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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-01-1230-01 — IVDD — General IVDD by GOODGUT, SLU

MD Atlas
GOODGUT, SLU

EUDAMED last updated this device on Feb 12, 2026

CRC-01-1230-01

B-08437023437193

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GOODGUT, SLU
UDI-DI code: 08437023437193
Reference / catalog number: CRC-01-1230-01

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Manufacturer information

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

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW097
Suspected of damaging fertility or the unborn child.
CW137
Obtain special instructions before use. Please, see the IFU
CW138
Do not handle until all safety precautions have been read and understood.
CW167
Wear protective gloves/ protective clothing/ eye protection/ face protection.
CW313
Get medical advice/ attention.

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: 08437023437193
Basic UDI-DI: B-08437023437193
Reference / catalog number: CRC-01-1230-01
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: RAID-CRC (Risk-Assessment Intestinal Disease – Colorectal Cancer) is a non-invasive tool based on faecal bacterial markers to differentiate subjects with advanced colorectal neoplasia (advanced adenoma and/or colorectal cancer (CRC)) from subjects with normal colonoscopy and non-advanced adenomas, composed of 8 species or groups that have been related with both favourable and unfavourable aspects of intestinal health by recent scientific literature. Two variants of the RAID-CRC test/kit exist according to its target population, which are subjects at intermediate or high risk of suffering from CRC, defined as follows: 1. Screening population. Asymptomatic subjects aged between 50 and 69 (both included), who obtained a positive result in the faecal immunochemical test (FIT) in the Catalan CRC screening programme. The FIT cut-off from which patients were considered positive was 20 μg haemoglobin/g of faeces (FIT20). This population was used to develop RAID-CRC Screen kit. 2. Symptomatic population. Subjects that showed any symptom related to the presence of CRC. These symptoms are presence of blood in stool, unexplained tiredness, unexplained weight loss, changes in bowel habits, and abdominal pain. This population was used to develop RAID-CRC Symptomatic kit. [EN]
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

Batch number
Expiration date
Manufacturing date
Serial number
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.