EU → North America Device Access

BIOTECH DENTAL SMILERS

FR-MF-000047137 · France · Salon de Provence

BIOTECH DENTAL SMILERS is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Devices declared under this manufacturer

Catalogue references include FM2017-01, FM2017-02, FM2017-03, MYOSIMPLE, MYOSIMPLE STANDARD, MyoSimple Petit.

European nomenclature codes declared: Q010499.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBiotech Dental Smilers, SAS (FR) · FDA 3014701704
Devices in EUDAMED6
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN6
Found in the U.S. device database6
Share100.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBIOTECH DENTAL SMILERS

North American profile: Both markets. BIOTECH DENTAL SMILERS is registered in both the United States and Canada.

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