EU → North America 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: Cancellous Screw - 32mm Threaded, Torx, Cortical Screw - Cross Drive, Cortical Screw - Removable Inserter, Cortical Screw, Torx, Cortical Screw, Torx - Extremity System.

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

Devices declared under this manufacturer

Showing 12 of 1 601 declared devices.

Catalogue references include 09.11.01.35000, 15.04.01.24006.A, 15.04.03.27016.A, 15.04.07.17010, 15.04.07.23022, 15.14.01.35016.

European nomenclature codes declared: P09120699, P09120601, P09120602, S010401, L0999, L091304.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 601
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 GTIN1 601
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. Astrolabe - Fabricação de Implantes Médicos, Lda was not found in either the U.S. or the Canadian register.

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