EU → North America Device Access

FISIOLINE SRL

IT-MF-000027924 · Italy · VERDUNO

FISIOLINE SRL is registered in the European database on medical devices as a manufacturer, with 157 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb146
Class IIa11

Most frequent device types declared: LUMIX 250, LUMIX C.P.S., LUMIX CPS, LUMIX CW, LUMIX PLUS.

Among these devices, 149 are declared active.

Devices declared under this manufacturer

Showing 12 of 157 declared devices.

Catalogue references include LCPS901, LPLUS1001, LPLUS13HP, LPLUS1601HP, LPLUS1602, LSURG1101D.

European nomenclature codes declared: Z120615, Z12011016, Z120602, Z120607, Z120601, Z120606.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryFISIOLINE S.R.L. (IT) · FDA 3004027973
Devices in EUDAMED157
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN157
Found in the U.S. device database78
Share49.7 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

Other manufacturers in Italy

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