EU → North America 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 has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb533
Class I1

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

Devices declared under this manufacturer

Showing 12 of 534 declared devices.

Catalogue references include 06037, 06062, 06081, 06167, 06178, 06261.

European nomenclature codes declared: H010202020301, H010202020302, H010201020101, H010201010501, H010201010101, H010201020102.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryLABORATORIOS SL SA (AR) · FDA 3003916006
Devices in EUDAMED534
Country of registrationSpain

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN534
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.

Notified body certificates

CertificateStatusExpiry
2025 DR 0061issued2030-07-17
2025 CR 0057issued2030-07-17

Other manufacturers in Spain

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