EU → North America Device Access

MESOTECH SRL

IT-MF-000011007 · Italy · NAPOLI

MESOTECH SRL is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa26

Among these devices, 1 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 26 declared devices.

Catalogue references include GUA01B, GUA01E, GUA02B, GUA03, GUA07A, GUA07C.

European nomenclature codes declared: M030405, B0599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED26
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 GTIN26
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. MESOTECH SRL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030205-00issued2031-07-12

Other manufacturers in Italy

All Italy manufacturers →