EU → North America Device Access

3A HEALTH CARE S.r.l.

IT-MF-000009298 · Italy · Lonato del Garda

3A HEALTH CARE S.r.l. is registered in the European database on medical devices as a manufacturer, with 119 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa114
Class IIb5

Most frequent device types declared: A3 Complete Nasal Shower (NEB5006), ASPEED 2 – 2 POMPE, Ampolla NEBJET - LTR141 (NEB225), HOSPYNEB professional, Kit accessori ADAPTAIR N300K2 (NEB1001).

Among these devices, 65 are declared active.

Devices declared under this manufacturer

Showing 12 of 119 declared devices.

Catalogue references include AP7005A, AP700A, AS906A, NE-C105-UK, NE-C303K-KDE, NE-C303K-KDITA.

European nomenclature codes declared: R060101, Z12159099, Z120105, Z12159002, Q030199, A060399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED119
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 GTIN119
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. 3A HEALTH CARE S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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