EU → North America Device Access

loren s.r.l.

IT-MF-000046689 · Italy · MONTEBELLUINA

loren s.r.l. is registered in the European database on medical devices as a manufacturer, with 1 968 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 968

Most frequent device types declared: CALZATURA ORTOPEDICA PREDISPOSTA.

Devices declared under this manufacturer

Showing 12 of 1 968 declared devices.

Catalogue references include 61024.75T.001-02, 61033.83T.001-01, 61034.83T.002-02, A1199.91M.001-01, A2000-17, A2009-04.

European nomenclature codes declared: Y063303.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 968
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 GTIN1 968
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. loren s.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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