EU → North America Device Access

Modulpac AB

SE-MF-000024685 · Sweden · Lagan

Modulpac AB is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Among these devices, 3 are declared with a measuring function.

Devices declared under this manufacturer

Catalogue references include 7240008001, 8010001001, 8040004001, 8040004002, 8050001001, 8200003001.

European nomenclature codes declared: A99, A020199, A020299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN10
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. Modulpac AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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