EU → North America Device Access

SLEE medical GmbH

DE-MF-000041949 · Germany · Nieder-Olm

SLEE medical GmbH is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Most frequent device types declared: Covertec, MPS 1, MPS C, MPS CX, MPS P.

Devices declared under this manufacturer

Catalogue references include 10170000, 10175000, 10190000, 10190001, 11000200, 11000700.

European nomenclature codes declared: W0202059009, W0202059012, W02029099, W0299, W0202059010, W0202059008.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySLEE MEDICAL GMBH (DE) · FDA 3008399755
Devices in EUDAMED12
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN12
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. SLEE medical GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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