EU → North America Device Access

H & D S.R.L.

IT-MF-000036620 · Italy · Parma

H & D S.R.L. is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: FRASB, IFRAS5, MSAT, d-ROMs.

Devices declared under this manufacturer

Showing 12 of 41 declared devices.

Catalogue references include CS01F5, DROLAB200, IKIT20, MRF, MROBOG5, REDOXOBDP10.

European nomenclature codes declared: W01019099, W0201010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED41
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 GTIN41
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. H & D S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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