EU → US Device Access

Planmed Oy

FI-MF-000006837 · Finland · Helsinki

Planmed Oy is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb8

Among these devices, 8 are declared 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 registerRegistered with FDA
Matched entryPlanmed Oy (FI) · FDA 8043728
Devices in EUDAMED8
Country of registrationFinland

Notified body certificates

CertificateStatusExpiry
FI23/0000004supplemented2027-01-23
FI23/0000004reissued2029-08-04

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