EU → US Device Access

Astrolabe - Fabricação de Implantes Médicos, Lda

PT-MF-000016588 · Portugal · Vialonga

Astrolabe - Fabricação de Implantes Médicos, Lda is registered in the European database on medical devices as a manufacturer, with 1 601 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb1 379
Class IIa222

Most frequent device types declared: Locking Screw - Variable Angle, Torx, Locking Screw - Torx, Cortical Screw, Torx, Cortical Screw - Cross Drive, Locking Screw, Torx - Extremity System.

Among these devices, 1 are declared sterile, 1 379 implantable, 222 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 EUDAMED1 601
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.

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