EU → North America Device Access

SISSEL GmbH

DE-MF-000007624 · Germany · Bad Dürkheim

SISSEL GmbH is registered in the European database on medical devices as a manufacturer, with 151 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa151

Most frequent device types declared: Ball, Fitband, Myofascia Roller, SISSEL ® Sit Air, SISSEL® Kinesiology Tape.

Devices declared under this manufacturer

Showing 12 of 151 declared devices.

Catalogue references include 110.003, 150.015, 150.111, 160.012, 162.030, 162.203.

European nomenclature codes declared: Z120602, V080302, M9001, Y0504, M030403, Z120621.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED151
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN151
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. SISSEL GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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