EU → North America Device Access

QUANTEL MEDICAL

FR-MF-000009724 · France · COURNON D'AUVERGNE CEDEX

QUANTEL MEDICAL is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb12
Class IIa5

Most frequent device types declared: Fixed-Height Tower, PABX0041HSDI, PABX0041ZEDI, PABX0041ZESI.

Among these devices, 17 are declared active, 5 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include C.STIM, MULTIFRAX, OPTIMIS FUSION, PABX0041HSSI, PABX0041ZESI, PEBX0005CDIAG.

European nomenclature codes declared: Z12011011, Z12011017, Z11040107, Z12011016, Z12120199, Z12120299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryQUANTEL MEDICAL (FR) · FDA 9680671
Devices in EUDAMED17
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN17
Found in the U.S. device database10
Share58.8 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryQUANTEL MEDICAL

North American profile: Both markets. QUANTEL MEDICAL is registered in both the United States and Canada.

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