EU → North America Device Access

NIHON KOHDEN FIRENZE S.r.l.

IT-MF-000007607 · Italy · Sesto Fiorentino

NIHON KOHDEN FIRENZE S.r.l. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: Detergent, Diluent, Lysing reagent for RBC, Lysing reagent for WBC, Stain reagent.

Devices declared under this manufacturer

Catalogue references include MEK-520I, MEK-620I, MEK-640I, MEK-641I, MEK-680I, MK-110WI.

European nomenclature codes declared: W0103010105, W0103010199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. NIHON KOHDEN FIRENZE S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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