EU → North America 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.

Devices declared under this manufacturer

Catalogue references include 20009418, 20009947, 30010465, 30022041, 30046641, 30063790.

European nomenclature codes declared: Z11039099, Z11030202, Z1103028001.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPlanmed Oy (FI) · FDA 8043728
Devices in EUDAMED8
Country of registrationFinland

Device-level evidence

Devices with a numeric GTIN8
Found in the U.S. device database2
Share25.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryPLANMED OY

North American profile: Both markets. Planmed Oy is registered in both the United States and Canada.

Notified body certificates

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

Other manufacturers in Finland

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