EU → US Device Access

PROHS Equipamento Hospitalar e Serviços Associados S.A.

PT-MF-000002798 · Portugal · Maia

PROHS Equipamento Hospitalar e Serviços Associados S.A. is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa50
Class IIb42

Most frequent device types declared: PJ 600L 1PD (68*68*130), FJ 340L 1PD (70*70*70), PJ 740L 1PD (68*68*160), PJ 325L 2PD (50*50*130), PJ 360L 2PD (60*60*100).

Among these devices, 92 are declared active.

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 EUDAMED92
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.

Notified body certificates

CertificateStatusExpiry
ES23/00000293amended2028-03-23

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