EU → US Device Access

Haco Tellus AB

SE-MF-000053610 · Sweden · ÅKERSBERGA

Haco Tellus AB is registered in the European database on medical devices as a manufacturer, with 868 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa868

Most frequent device types declared: ALU MB 200X45 (60-8), DÄCK 2.50-3 GRÅ C-248, SLANG 3.00-8 BV VINKLAD, LUPO 16X1.75 GRÅ C-97 OK M12, DRIVRING SOFTGREPP 24.

Among these devices, 868 are declared reusable.

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 EUDAMED868
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.

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