EU → North America Device Access

D.R.M. S.R.L.

IT-MF-000027115 · Italy · POGGIO RUSCO

D.R.M. S.R.L. is registered in the European database on medical devices as a manufacturer, with 305 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa305

Most frequent device types declared: COPRIAGO, Dispositivi Premifistola, Garze e tamponi sterili, Kit medicazione dialisi sterili, Kit medicazione generica sterili.

Among these devices, 285 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 305 declared devices.

Catalogue references include DR 1202/CVC/SG, DR 128/NO/2, DR 161/B-1/, DR 187/FAV/3, DR/CS/ASUR, DR/CVC/1R.

European nomenclature codes declared: T0203, M030404, M04010201, T0299, Y090699, V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED305
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 GTIN305
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. D.R.M. S.R.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
55998issued2028-01-24
55998reissued2028-01-24

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