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Organization name
UDI-DI code
Reference / catalog number

TUG-01-1024 — IVDD — General IVDD by GOODGUT, SLU

MD Atlas
GOODGUT, SLU

EUDAMED last updated this device on Aug 4, 2025

TUG-01-1024

B-08437023437056

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GOODGUT, SLU
UDI-DI code: 08437023437056
Reference / catalog number: TUG-01-1024

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Manufacturer information

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

Critical warnings

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

CW010
Follow the basic instructions of a laboratory that performs qPCR testing and biological analysis. eIFU available.
CW137
Please, see the eIFU, check de URL or quick use guide inside of the box.
CW149
Our recommendation is to keep reagents in the general packaging to maintain traceability and minimize any risk of confusion.

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: 08437023437056
Basic UDI-DI: B-08437023437056
Reference / catalog number: TUG-01-1024
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 TestUrGut qPCR kit diagnoses gut dysbiosis by qPCR detection of specific microbial markers in stool samples. The test allows to know the patient's intestinal health and diagnose intestinal dysbiosis. The panel of markers included in the TestUrGut qPCR kit is composed of 15 microbial markers belonging to different functional groups (proteolytic, balance, immunoprotective, muconutritive, pro-inflammatory, methanogenic, and yeast). They are represented by the following microbial groups: Eubacteria, Escherichia coli, Faecalibacterium prausnitzii, Ruminococcus spp., Akkermansia muciniphila, Methanobrevibacter smithii, Clostridium cluster I, Enterococcus sp., Roseburia sp., Clostridium cluster XIV, Gammaproteobacteria, Lactobacillus sp., Bacillota, Bacteroidota, and Candida albicans. The TestUrGut qPCR kit allows to amplify and quantify the characteristic gene fragments of the microorganisms. The results are provided quantitatively through an easy-to-interpret report. The product is not automatic. The intended user is the 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

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.