EU → US Device Access

Produtos Médicos Hospitalares, SA

PT-MF-000007631 · Portugal · Samora Correia

Produtos Médicos Hospitalares, SA is registered in the European database on medical devices as a manufacturer, with 1 703 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 703

Most frequent device types declared: 313.1978, 703.0613, 702.2978, 201.0248, 703.0637.

Among these devices, 1 630 are declared sterile.

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 EUDAMED1 703
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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