EU → North America Device Access

Delcon Srl

IT-MF-000014234 · Italy · Grassobbio (BG)

Delcon Srl is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa47

Most frequent device types declared: Fixing/Cleaning solution, Hematology Fixative/Cleaning solution.

Among these devices, 47 are declared active.

Devices declared under this manufacturer

Showing 12 of 66 declared devices.

Catalogue references include HMIX3.WIFIG.BR, HMIX4.42, HWELD-MC.DB.00G.BR, HWELD-T.DB.00G.BR, HWG2.00VDP, MAC2.BR.WIFI.

European nomenclature codes declared: B0180, W0104010804, Z121799.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDELCON SRL (IT) · FDA 3014345398
Devices in EUDAMED66
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN66
Found in the U.S. device database21
Share31.8 %

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. Delcon Srl is registered in the United States but was not found in the Canadian register.

Other manufacturers in Italy

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