EU → US Device Access

Fapomed- Dispositivos Médicos, S.A.

PT-MF-000004129 · Portugal · Felgueiras

Fapomed- Dispositivos Médicos, S.A. is registered in the European database on medical devices as a manufacturer, with 354 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa354

Most frequent device types declared: Surgical Drape (Anesthesia), Surgical Gown (Reinforced), Surgical Drape (Cardiovascular), Clean Air Suit, Equipment Cover (Reinforced Instrument cover).

Among these devices, 351 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 EUDAMED354
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.

Other manufacturers in Portugal

All Portugal manufacturers →