EU → North America Device Access

MEDI-LINE S.r.l.

IT-MF-000019935 · Italy · Reggio di Calabria (RC)

MEDI-LINE S.r.l. is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11
Class IIb3

Most frequent device types declared: ACTIVA, Neovac, Pushbag, SECURA Basic, Secura.

Among these devices, 14 are declared sterile, 3 active.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include 04-200, 300-R3, 300-T5, 300-v3, 400-213MR, 400-314MR.

European nomenclature codes declared: K01010103, C0101010201, C0101010202, K01020107, K01010104, K01010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
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 GTIN14
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. MEDI-LINE S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
CSQ0003220524supplemented2027-12-27
CSQ000322issued2027-12-27

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