EU → North America Device Access

Mediplast AB

SE-MF-000000885 · Sweden · Malmö

Mediplast AB is registered in the European database on medical devices as a manufacturer, with 273 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa273

Among these devices, 13 are declared sterile.

Catalogue references include 6050406, 6050432, 6051108B, 6051118R, 60701015, 60701302.

European nomenclature codes declared: M03030201, M0303010101, M030402020101, R9080, A0399, M04010101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDIPLAST AB (SE) · FDA 8020659
Devices in EUDAMED273
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN273
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: United States only. Mediplast AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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