EU → North America 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 IIb42
Class IIa50

Most frequent device types declared: FJ 145L 2PD (40*40*90), FJ 340L 1PD (70*70*70), FJ 640L 2PD (70*70*130), FJ 70L 1PD (32*32*70), FJ 740L 1PD (70*70*150).

Among these devices, 92 are declared active.

Devices declared under this manufacturer

Showing 12 of 92 declared devices.

Catalogue references include Advance Automatic Door, FJ 175L 2PD (50*50*70), FJ 340L 1PD (70*70*70), FJ 490L 1PD (70*70*100), FJ 930L 2PD (70*70*190), PJ 250L 2PD (50*50*100).

European nomenclature codes declared: Z12011304.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED92
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 GTIN92
Found in the U.S. device database0
Share0.0 %

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. PROHS Equipamento Hospitalar e Serviços Associados S.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ES23/00000293amended2028-03-23

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