EU → US Device Access

Svan Care AB

SE-MF-000049398 · Sweden · Ludvika

Svan Care AB is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa38

Most frequent device types declared: Balance Modular Toilet Aid System, Bidette R3/M3/P12 Spol- och torktoalett, Svan Lift Höj-och sänkbar toalett, Lift Easy Höj-och sänkbar toalett, Klara RIK-sits för kateterisering.

Among these devices, 38 are declared reusable, 16 active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED38
Country of registrationSweden
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in Sweden

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