EU → North America Device Access

HOPI MEDICAL

FR-MF-000038707 · France · ROSHEIM

HOPI MEDICAL is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: FMC, HOPACK, LIMSTAR, WALLET, WALLIGHT.

Devices declared under this manufacturer

Catalogue references include FMC, HOPACK, LIMSTAR, MINILIM, WALLET, WALLIGHT.

European nomenclature codes declared: V92,Z12030692.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHOPI MEDICAL SA (FR) · FDA 3042243260
Devices in EUDAMED6
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN6
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. HOPI MEDICAL is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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