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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-CRC-es — IVDR Class A IVDR by GOODGUT, SLU

MD Atlas
GOODGUT, SLU

EUDAMED last updated this device on Sep 14, 2023

SCK-04-CRC-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: 08437023437070
Reference / catalog number: SCK-04-CRC-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	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437023437070
Basic UDI-DI: 8437023437SCKAT
Reference / catalog number: SCK-04-CRC-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. like to RAID-CRC, RAID-Dx and TestUrGut test. 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, -Shipping package category (UN3373). -Analysis (instructions) form for posterior analysis of faecal microbiota.
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.