EU → North America Device Access

Albert Polska Sp. z o.o.

PL-MF-000007130 · Poland · Dobczyce

Albert Polska Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Most frequent device types declared: Mini (10 x10 cm), Standard (10 x 26 cm), Medium (19 x 22 cm), Max (19 , nr 2, nr 7, nr 9, nr 11, nr 5, nr 7, nr 9, nr 11.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 0000000000839, 0000000001206, 0000000001219, 4111200070000, 5907438901778, 8111200000000.

European nomenclature codes declared: G02060399, M9001, Q03040299, Z12019007.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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 GTIN13
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. Albert Polska Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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