EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 751 declared devices.

Catalogue references include DA-0112-801, DSL-0837-50, DT2-0618-61, DT2-0684-11, DT2-0851-70, DT2-1015-70.

European nomenclature codes declared: P09120503, L091002, L091001, L091099, L0927, L098099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED751
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 GTIN751
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. DELPHOS IMPLANTS – Indústria, Comércio, Importação e Exportação de Implantes Médicos, S.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
HZ 1715160-1supplemented2030-07-07

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