EU → North America Device Access

Planmeca Oy

FI-MF-000006499 · Finland · Helsinki

Planmeca Oy is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb26
Class IIa21

Among these devices, 43 are declared active, 7 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 47 declared devices.

Catalogue references include 30003107, 30003109, 30010469, 30013450, 30016946, 30020366.

European nomenclature codes declared: Z11030380, Z12110101, Z11030302, Z1103040102, Z110601, Z1103040101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPlanmeca Oy (FI) · FDA 8030876
Devices in EUDAMED47
Country of registrationFinland

Device-level evidence

Devices with a numeric GTIN47
Found in the U.S. device database26
Share55.3 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryPLANMECA OY

What it holds in Canada

Licences on record9
Currently active0
Class 2 devices7
Class 3 devices2
First licensed2004-11-25

Licence types: System (5), Device Group Family (3), Single Device (1).

Licensed under: PLANMECA PROONE, DIGITAL PANORAMIC X-RAY SYSTE, PLANMECA PROSENSOR HD DIGITAL INTRAORAL X-RAY , PLANMECA ROMEXIS, PLANMECA PROMAX 3D (CBVT DENTAL X-RAY SYSTEMS), PLANMECA PROX - INTRAORAL X-RAY SYSTEM, PLANMECA VISO.

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

Notified body certificates

CertificateStatusExpiry
FI23/00000059supplemented2028-12-27
FI23/00000059supplemented2030-06-26

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