EU → North America Device Access

NEOMEDLIGHT

FR-MF-000004044 · France · Villeurbanne

NEOMEDLIGHT is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa14

Most frequent device types declared: BCC010, BCC101, BCC111, BCC121, BCC201.

Among these devices, 4 are declared active.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include BCC111, BCC121, BCC201, BCC211, BCC221, CM201.

European nomenclature codes declared: Z12080401, Z12040202, Z12080485, Z12040285, Z12080499.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNEOMEDLIGHT (FR) · FDA 3013919653
Devices in EUDAMED14
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN14
Found in the U.S. device database5
Share35.7 %

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. NEOMEDLIGHT is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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