EU → North America Device Access

LEMER PAX

FR-MF-000003579 · France · Carquefou

LEMER PAX is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb3
Class IIa20

Most frequent device types declared: Cathpax, Dose calibrator, Equipement amagnétique, Injector, Sterile kit Cathkit.

Among these devices, 4 are declared sterile, 5 active, 2 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include 00007305, 00008668, 00008672, 00019530, 00027654, 00033012.

European nomenclature codes declared: V9099, Z11029099, T0299, V080504, Z11029005, V080502.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLEMER-PAX (FR) · FDA 3003808764
Devices in EUDAMED23
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN23
Found in the U.S. device database2
Share8.7 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryLEMER PAX

What it holds in Canada

Licences on record2
Currently active0
Class 2 devices2
First licensed2025-08-14

Licence types: Single Device (2).

Licensed under: ACCURION 226, POSIJET.

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

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