EU → North America Device Access

Grasant Sp. z o.o.

PL-MF-000035417 · Poland · Krapkowice

Grasant Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: Podkład medyczny Karen 50 cm x 50 mb.

Devices declared under this manufacturer

Catalogue references include 850100, 85050V, 85080, 85080V, 860100, 86050.

European nomenclature codes declared: T030502.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationPoland

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

Device-level evidence

Devices with a numeric GTIN11
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. Grasant Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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