EU → North America Device Access

1M4 OÜ

EE-MF-000040367 · Estonia · Tallinn

1M4 OÜ is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa42

Among these devices, 1 are declared active.

Catalogue references include 10014.00, 10020.00, 10029.00, 10036.00, 10048.00, 11000.00.

European nomenclature codes declared: C9005, Q0299, Q03040299, V030207, C020180, V9003.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED42
Country of registrationEstonia

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN42
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. 1M4 OÜ was not found in either the U.S. or the Canadian register.

Other manufacturers in Estonia

All Estonia manufacturers →