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Labsystems Diagnostics Oy

FI-MF-000018281 · Finland · Vantaa

Labsystems Diagnostics Oy is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other75

Most frequent device types declared: 5550300, 8100533, 8100411, 6111320, 8100442.

Among these devices, 6 are declared sterile.

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 registerRegistered with FDA
Matched entryLABSYSTEMS DIAGNOSTICS (FI) · FDA 3005342322
Devices in EUDAMED75
Country of registrationFinland

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