EU → North America Device Access

GOODGUT, SLU

ES-MF-000000229 · Spain · GIRONA

GOODGUT, SLU is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: RAID-CRC SCREEN, RAID-CRC Screen, RAID-CRC Symptomatic qPCR Kit, RAID-Dx qPCR Kit HP, RAID-Dx qPCR Kit LP.

Devices declared under this manufacturer

Catalogue references include CRC-01-2250-01, DX-02-1024-01-LP, DX-02-2024-01-HP, PLAT-03-020700, SCK-04-CRC-es, SCK-04-DX-es.

European nomenclature codes declared: W0101060399, W05019001, W02060292.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationSpain

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. GOODGUT, SLU was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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