EU → US Device Access

BHL-Medical, Indústria de Produtos Hospitalares, lda

PT-MF-000002811 · Portugal · Santo Estêvão das Galés

BHL-Medical, Indústria de Produtos Hospitalares, lda is registered in the European database on medical devices as a manufacturer, with 187 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa187

Most frequent device types declared: BHL-HiFlow, BHL-ContrastCare Line, BHL-InfuCare line, BHL-Singleflow , Transflux .

Among these devices, 186 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 EUDAMED187
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
ITD 1450490 1supplemented2030-01-13

Other manufacturers in Portugal

All Portugal manufacturers →