EU → North America Device Access

LIPOELASTIC a.s.

CZ-MF-000002396 · Czechia · Praha 5

LIPOELASTIC a.s. is registered in the European database on medical devices as a manufacturer, with 1 742 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa1 742

Devices declared under this manufacturer

Showing 12 of 1 742 declared devices.

Catalogue references include LIPO-ACTIVE-P-S, LIPO-ACTIVE-WW-XXL+, LIPO-MTmL00C00R-B-XS, LIPO-PI01C00X-W-75C, LIPO-PI19V00R-B-3XL, LIPO-PI35V00R-N-75BC.

European nomenclature codes declared: M030499, M030405.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLIPOELASTIC A.S. (CZ) · FDA 3008863514
Devices in EUDAMED1 742
Country of registrationCzechia

Device-level evidence

Devices with a numeric GTIN1 742
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. LIPOELASTIC a.s. is registered in the United States but was not found in the Canadian register.

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