EU → North America Device Access

Megin Oy

FI-MF-000011965 · Finland · Espoo

Megin Oy is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: NM23900N, NM25000N, NM26000N, SW23380N, SW23732N.

Among these devices, 6 are declared active, 4 with a measuring function.

Devices declared under this manufacturer

Catalogue references include NM23900N, NM25000N, NM26000N, SW23380N, SW23732N, SW24051N.

European nomenclature codes declared: Z12101201, Z12101292.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEGIN OY (FI) · FDA 9680891
Devices in EUDAMED6
Country of registrationFinland

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database5
Share100.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMEGIN OY

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2019-12-09

Licence types: System (3).

Licensed under: TRIUX NEO, TRIUX NEO WITH MEGFLOW, MEGREVIEW.

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

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