EU → North America Device Access

NEWCARD

FR-MF-000029884 · France · Wambrechies

NEWCARD is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Catalogue references include 1 Minute Pour mes Reins, 1 Minute Pour mon Cœur, MPC-PS-ALL, MPR / Tablette / Balance, MPR-PS-ALL.

European nomenclature codes declared: Z12040192.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN3
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. NEWCARD was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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