EU → North America Device Access

A. J. Costa (Irmãos), Lda.

PT-MF-000018247 · Portugal · Cacém

A. J. Costa (Irmãos), Lda. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include Amaro 5000 AJC 7070100-1D GI, Amaro 5000 AJC 7070100-2D GI, Amaro 5000 AJC 7070125-1D GI, Amaro 5000 AJC 707070-1D GI, Amaro 5000 AJC 707070-2D GI.

European nomenclature codes declared: S9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. A. J. Costa (Irmãos), Lda. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ES23/00000028issued2028-01-11

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