EU → North America Device Access

adapsia

FR-MF-000011356 · France · LYON

adapsia is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa12

Among these devices, 12 are declared reusable.

Devices declared under this manufacturer

Catalogue references include 230-057, 230-061, 230-063, 230-068, 230-160, 230-163.

European nomenclature codes declared: L091002, L091001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

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: Neither register. adapsia was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
HZ 1528553-1issued2028-05-10

Other manufacturers in France

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