EU → North America Device Access

MEDEX

FR-MF-000000414 · France · SAINT PRIEST

MEDEX is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa43

Most frequent device types declared: FSDMU110, FSDMU120, FSDMU210, FSDSU110, MFDS03.

Among these devices, 39 are declared sterile, 2 active, 3 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 43 declared devices.

Catalogue references include FSDMU210, FSDSU211, FSDSU231, MFSV01, QIT005, QIT021.

European nomenclature codes declared: A030499, A020102010202, A03020101, A040199, A0703, G02060399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDEX (FR) · FDA 3012261967
Devices in EUDAMED43
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN43
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMEDEX

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2022-10-31

Licence types: Device Group (2), Single Device (1).

Licensed under: SECUFILL, MANYFILL SCANBAGS, MANYFILL VIALS.

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

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