EU → North America Device Access

Invacare Portugal, Unipessoal Lda.

PT-MF-000006551 · Portugal · Leça do Balio

Invacare Portugal, Unipessoal Lda. is registered in the European database on medical devices as a manufacturer, with 684 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa684

Among these devices, 534 are declared active.

Devices declared under this manufacturer

Showing 12 of 684 declared devices.

Catalogue references include 1575921-7035, 1575992-7035, 1605983-7042, 1650099, 1655787, 1682765.

European nomenclature codes declared: V08060101, V0805038002, V0805030102, V0806010701, V080699, V08050302.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED684
Country of registrationPortugal

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

Device-level evidence

Devices with a numeric GTIN684
Found in the U.S. device database2
Share0.3 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. Invacare Portugal, Unipessoal Lda. was not found in either the U.S. or the Canadian register.

Other manufacturers in Portugal

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