EU → North America Device Access

POLAAR

FR-MF-000021372 · France · Lagny sur Marne

POLAAR is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Attelle Pieds, Attelle Pieds / Cheville, Attelle Poignet / main / pouce, Attelle ceinture abdominales / hanche, Attelle genou articulée.

Devices declared under this manufacturer

Catalogue references include CHE1, DOS1, GEN1, GEN2, HAN1, PIE1.

European nomenclature codes declared: Y061216, Y060499, Y060609, Y060613, Y060308, Y06120601.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
Country of registrationFrance

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

Device-level evidence

Devices with a numeric GTIN8
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. POLAAR was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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