EU → North America Device Access

Air Liquide Medical Systems S.r.l.

IT-MF-000015627 · Italy · Milano

Air Liquide Medical Systems S.r.l. is registered in the European database on medical devices as a manufacturer, with 400 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa374
Class IIb26

Among these devices, 66 are declared active.

Devices declared under this manufacturer

Showing 12 of 400 declared devices.

Catalogue references include 401168, 437058, 437070, 471293, 471383, 471470.

European nomenclature codes declared: R03010380, R0301010201, R0301010202, Z12159002, Z120105, R9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED400
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN400
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryAIR LIQUIDE MEDICAL SYSTEMS S.R.L.

What it holds in Canada

Licences on record24
Currently active0
Class 2 devices24
First licensed2016-04-05

Licence types: Single Device (14), Device Family (10).

Licensed under: RESPIREO SOFT BABY, RESPIREO PRIMO P NON VENTED, RESPIREO PRIMO P, RESPIREO SOFT BABY NON VENTED, RESPIREO SOFT NASAL, RESPIREO HOSPITAL F NON VENTED REUSABLE.

North American profile: Canada only. Air Liquide Medical Systems S.r.l. holds a Canadian licence but was not found in the U.S. register.

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