EU → North America Device Access

Tjugohundra18 AB

SE-MF-000003776 · Sweden · Halmstad

Tjugohundra18 AB is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa46

Most frequent device types declared: 11058, 50003, 50004, 55000, 55002.

Devices declared under this manufacturer

Showing 12 of 46 declared devices.

Catalogue references include 11058, 50003, 50004, 55000, 55002, 55005.

European nomenclature codes declared: Y0999, T0499, V0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED46
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 GTIN46
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. Tjugohundra18 AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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