EU → North America Device Access

Bisniflex S.r.l.

IT-MF-000056543 · Italy · POGGIBONSI

Bisniflex S.r.l. is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: Comfy, Dinamico, Dinamico Plus, Lattice 100% Naturale, Lattice Alta Densità ADX.

Catalogue references include Comfy, Dinamico, Dinamico Plus, Lattice 100% Naturale, Linfa, Memo.

European nomenclature codes declared: V080702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
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 GTIN16
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. Bisniflex S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →