EU → North America Device Access

Liofilchem S.r.l.

IT-MF-000026495 · Italy · Roseto Degli Abruzzi

Liofilchem S.r.l. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Most frequent device types declared: 90 mm agar plates, Mannitol Salt Agar.

Catalogue references include $10459, 10030, 92063, 920630, 920631.

European nomenclature codes declared: W0104080501, W0104010405, W0104010403.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLIOFILCHEM S.R.L. (IT) · FDA 3012389632
Devices in EUDAMED5
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryLIOFILCHEM S.R.L.

What it holds in Canada

Licences on record4
Currently active0
Class 2 devices4
First licensed2012-02-28

Licence types: Device Family (4).

Licensed under: MIC (MINIMUM INHIBITORY CONCENTRATION) TEST ST, ANTIBIOTIC DISCS FOR SUSCEPTIBILITY TESTING, COMASP, AD FOSFOMYCIN.

North American profile: Both markets. Liofilchem S.r.l. is registered in both the United States and Canada.

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