EU → North America Device Access

Giesse Technology S.r.l.

IT-MF-000031331 · Italy · Cogoleto (Genova)

Giesse Technology S.r.l. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: GS EBR ANA A, GS EBR ANA C, GS IAC ANA BC, GS IAC TRA A, TWIN ATTIVA ANALOGO Ø3,5.

Among these devices, 1 are declared reusable.

Devices declared under this manufacturer

Catalogue references include GS EBR ANA B, GS EBR ANA C, GS EBR TRA B, GS EBR TRA C, GS EBR TRA MCR, GS IAC ANA A.

European nomenclature codes declared: Q010280, Q010599, Q01020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN7
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. Giesse Technology S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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