EU → North America Device Access

ELINE S.R.L.

IT-MF-000029568 · Italy · Montecchio Precalcino

ELINE S.R.L. is registered in the European database on medical devices as a manufacturer, with 263 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa263

Most frequent device types declared: Crepe paper, Self-adhesive sterilization pouches, Sterilization pouches, Sterilization rolls.

Devices declared under this manufacturer

Showing 12 of 263 declared devices.

Catalogue references include 20320038, 20320060, 20320075, 20320082, 20320661, 20321208.

European nomenclature codes declared: S01010101, S010301, S01020101, S01020201, S01010201, S01020102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED263
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

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. ELINE S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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