EU → North America Device Access

M.D.L. S.r.l.

IT-MF-000011599 · Italy · Delebio

M.D.L. S.r.l. is registered in the European database on medical devices as a manufacturer, with 624 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa623

Most frequent device types declared: PB1710, PB2012, PJ0915, PJ1115, PM1815.

Among these devices, 622 are declared sterile, 1 reusable.

Devices declared under this manufacturer

Showing 12 of 624 declared devices.

Catalogue references include PB1710, PB2012, PJ0915, PJ1115, PM1815, PN2012.

European nomenclature codes declared: A0102010101, A01020201, A01020102, A010302, A018003, A019012.

United States market access

FDA establishment registerRegistered with FDA
Matched entryM.D.L. S.R.L. (IT) · FDA 3004749705
Devices in EUDAMED624
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN624
Found in the U.S. device database153
Share24.5 %

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: United States only. M.D.L. S.r.l. is registered in the United States but was not found in the Canadian register.

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