EU → US Device Access

DAVID MEDICAL EUROPE, UNIPESSOAL LDA

PT-MF-000042894 · Portugal · Santa Maria da Feira, Aveiro

DAVID MEDICAL EUROPE, UNIPESSOAL LDA is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb11
Class IIa4

Most frequent device types declared: N-200/N-500/N-520/N-550/N-600, W-300/W-500/W-600, P-200/P-300/P-500, T-500/T-800, D-100.

Among these devices, 15 are declared active, 12 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
Country of registrationPortugal
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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