EU → North America Device Access

Remeda AB

SE-MF-000003281 · Sweden · Halmstad

Remeda AB is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa13

Most frequent device types declared: 07350109400328, 15966.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 15966-01, 15966-02, 15966-33, 15966-44, 15966-91, 15966-92.

European nomenclature codes declared: S9080, Z12011299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryREMEDA AB (SE) · FDA 3013300766
Devices in EUDAMED13
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN13
Found in the U.S. device database12
Share92.3 %

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. Remeda AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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