EU → US Device Access

Laboratorio Aragó S.L.

ES-MF-000001958 · Spain · Barcelona

Laboratorio Aragó S.L. is registered in the European database on medical devices as a manufacturer, with 534 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb533
Class I1

Among these devices, 534 are declared sterile, 534 implantable.

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 EUDAMED534
Country of registrationSpain
⚠️ 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
2025 DR 0061issued2030-07-17
2025 CR 0057issued2030-07-17

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