EU → North America Device Access

Sterisets Manufacturing S.A.

PT-MF-000002822 · Portugal · Penafiel

Sterisets Manufacturing S.A. is registered in the European database on medical devices as a manufacturer, with 94 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa93
Class IIb1

Among these devices, 94 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 94 declared devices.

Catalogue references include 1120004, 3020002, 3040012, 3990125, 5019315, 5021848.

European nomenclature codes declared: V0402, A02010701, T020199, T04010299, M0304010101, M020107.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED94
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 GTIN94
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. Sterisets Manufacturing S.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Portugal

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