EU → North America Device Access

Lipogems International S.p.A.

IT-MF-000010159 · Italy · Milano

Lipogems International S.p.A. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa12

Among these devices, 12 are declared sterile.

Devices declared under this manufacturer

Catalogue references include LGD 120 B, LGD 120 O, LGD 120 S, LGD 240 B, LGD 60 B, LGD 60 M.

European nomenclature codes declared: V0599.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLIPOGEMS INTERNATIONAL S.P.A. (IT) · FDA 3010742783
Devices in EUDAMED12
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN12
Found in the U.S. device database12
Share100.0 %

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: United States only. Lipogems International S.p.A. is registered in the United States but was not found in the Canadian register.

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