EU → US Device Access

DELPHOS IMPLANTS – Indústria, Comércio, Importação e Exportação de Implantes Médicos, S.A.

PT-MF-000012964 · Portugal · São Domingos de Rana

DELPHOS IMPLANTS – Indústria, Comércio, Importação e Exportação de Implantes Médicos, S.A. is registered in the European database on medical devices as a manufacturer, with 751 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb531
Class IIa220

Among these devices, 531 are declared implantable, 130 reusable.

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 EUDAMED751
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
HZ 1715160-1supplemented2030-07-07

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