EU → North America Device Access

Multilens AB

SE-MF-000002792 · Sweden · Mölnlycke

Multilens AB is registered in the European database on medical devices as a manufacturer, with 2 015 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 015

Most frequent device types declared: ML Filter Solutions.

Devices declared under this manufacturer

Showing 12 of 2 015 declared devices.

Catalogue references include 315137, 323278, 325002, 35484, 38981, 39243.

European nomenclature codes declared: Q0210010199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 015
Country of registrationSweden

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN2 015
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. Multilens AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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