EU → North America Device Access

Human Care HC AB

SE-MF-000002090 · Sweden · Stockholm

Human Care HC AB is registered in the European database on medical devices as a manufacturer, with 121 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa121

Most frequent device types declared: 90300, 90500, 90600, Altair, B1041-TS-GEL.

Among these devices, 26 are declared active.

Devices declared under this manufacturer

Showing 12 of 121 declared devices.

Catalogue references include 11250Q6, 12415-1, 13315, 13425, 22144, 22241.

European nomenclature codes declared: Y1299, V08050399, V08060101, Y180918, Y181899, Y1899.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHUMAN CARE HC AB (SE) · FDA 8043351
Devices in EUDAMED121
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN121
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. Human Care HC AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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