EU → North America Device Access

HABYS Sp. z o.o.

PL-MF-000007133 · Poland · Jasło

HABYS Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 363 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa363

Most frequent device types declared: Estetic Dark, Klin 60x60x6 - nakładka na stół z wycięciem pod biust - k033, Klin rehab. 20x15x10 - k322 PVC, Krzesło do masażu Flexo biały k501, Leżanka Alexa - buk naturalny - k533.

Devices declared under this manufacturer

Showing 12 of 363 declared devices.

Catalogue references include G-KSKLK012101, G-KSKOK012001, G-KSPWK722011, G-KSPWK722019, T-KSWAK515005EKO, T-SKARENA001.

European nomenclature codes declared: Z120602, V080602, V08068099, V080202, M030402030103, V0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED363
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 GTIN363
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. HABYS Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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