EU → North America Device Access

Theraclion

FR-MF-000000496 · France · Malakoff

Theraclion is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb4
Class IIa4

Most frequent device types declared: THC800154, THC900800, THC903359, THC903359-B, THC903400.

Among these devices, 4 are declared active.

Devices declared under this manufacturer

Catalogue references include THC800154-D, THC800154-E, THC900800-C, THC901250-A, THC901500-A, THC903359-A.

European nomenclature codes declared: Z120610.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
Country of registrationFrance

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

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. Theraclion was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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