EU → North America Device Access

IDETEC SAS

FR-MF-000018489 · France · Nimes

IDETEC SAS is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb20

Most frequent device types declared: SD30 DR, SD30 P15, SD30 P32, SD30 P6, SD30C FPD+21.

Among these devices, 20 are declared active.

Devices declared under this manufacturer

Showing 12 of 20 declared devices.

Catalogue references include SD30 DR, SD30 P15, SD30 P6, SD30C S12, SD30CFPD+30, SD30T DR.

European nomenclature codes declared: Z11039016, Z11039017, Z11030701.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED20
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. IDETEC SAS was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
278/MDRissued2031-04-26

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