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Luneau Technology Operations

FR-MF-000009091 · France · Pont-de-l'Arche

Luneau Technology Operations is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa52

Most frequent device types declared: VX22, WAM 800, VX650, L900, VX65.

Among these devices, 1 are declared sterile, 31 active, 20 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLUNEAU TECHNOLOGY OPERATIONS (FR) · FDA 3009173773
Devices in EUDAMED52
Country of registrationFrance

Notified body certificates

CertificateStatusExpiry
160/MDRissued2029-05-15

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