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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

SCK-04-TUG-es — IVDR Class A IVDR by GOODGUT, SLU

MD Atlas
GOODGUT, SLU

EUDAMED last updated this device on Sep 25, 2023

SCK-04-TUG-es

8437023437SCKAT

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GOODGUT, SLU
UDI-DI code: 08437023437100
Reference / catalog number: SCK-04-TUG-es

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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.

Country	On market since	Until
SpainPrimary placement	Feb 13, 2019	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 08437023437100
Basic UDI-DI: 8437023437SCKAT
Reference / catalog number: SCK-04-TUG-es
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Stool Collection Kit is a non-sterile class A, rule 5 (c) collection kit for stool samples to be used with the other in vitro Medical Devices for diagnostic developed in GoodGut. It is composed of: -Universal container of polypropylene aseptically produced with spoon CE IVD self-certified, -Disposable nitrile glove powder free CE self-certified, -Toilet paper for stool sampling, -Protection bag for biological substances category B (UN3373), -Instructions for use detailing the sample collection (labeling packaging and instruction form), -Shipping package category (UN3373). -Analysis (instructions) form for posterior analysis of faecal microbiota. The target population of the Stool Collection Kit will be subjects who, through prescription of a specialist medical doctor or by its own, will require one of the analysis of the GoodGut’s medical devices, and need to collect and send the stool sample appropriately. Its use is domestic as it is intended to be used directly by the user at home, without the help of any qualified professional.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019001FAECES COLLECTION DEVICES

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.