EU → North America Device Access

B.I.M.A. PLASTTEKNIK AB

SE-MF-000001678 · Sweden · TRÄSLÖVSLÄGE

B.I.M.A. PLASTTEKNIK AB is registered in the European database on medical devices as a manufacturer, with 1 667 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 667

Most frequent device types declared: 73400473(C)05-SERIESVZ, 73400473(C)14-SERIESW5, 73400473(C)15-SERIESWQ, 73400473(C)24-SERIESWU, 73400473(C)54-SERIESYZ.

Devices declared under this manufacturer

Showing 12 of 1 667 declared devices.

Catalogue references include 05-4043-P, 15-4543-K-4, 22-10-4553-P-4, 50-4045-P, 50-5757-P, 60-3535-K.

European nomenclature codes declared: V080399, V0804, V080504.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 667
Country of registrationSweden

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

Device-level evidence

Devices with a numeric GTIN1 667
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. B.I.M.A. PLASTTEKNIK AB was not found in either the U.S. or the Canadian register.

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