EU → North America Device Access

SODEL

FR-MF-000000367 · France · LISIEUX

SODEL is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22
Class IIb6

Most frequent device types declared: F3324, F3324-Surf, F3422, F3423.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include 2000000289, 2000000290, 8000.002, EXS0031FR, EXS0038BE, EXS0041Z19E.

European nomenclature codes declared: D0902, D0901, D0701, D01010102, D99, D010103.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
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 GTIN28
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. SODEL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
40077issued2028-05-16
39947issued2028-05-16
39301supplemented2028-05-16

Other manufacturers in France

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