EU → North America Device Access

Westerstrand Urfabrik AB

SE-MF-000051590 · Sweden · TÖREBODA

Westerstrand Urfabrik AB is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: 119620-02, 119620-12, 119622-02, 119622-12, 119622-22.

Among these devices, 9 are declared active.

Devices declared under this manufacturer

Catalogue references include 119620-02, 119620-12, 119622-02, 119622-12, 119622-22, 119623-02.

European nomenclature codes declared: Y215199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. Westerstrand Urfabrik AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →