EU → North America Device Access

DBM SRL

IT-MF-000017565 · Italy · Tovo di S.Agata (SO)

DBM SRL is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa3
Class IIb7

Most frequent device types declared: D.B.M. C-LOCK, D.B.M. SALINEFLUSH, D.B.M. WATERFLUSH.

Among these devices, 10 are declared sterile.

Devices declared under this manufacturer

Catalogue references include PAG01NB1TG, PCE14KA2, PCE15KA2, PCF13MA1, PCG01MB1TG, PCG06NA1.

European nomenclature codes declared: A02010799, C0180, A02010702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN5
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. DBM SRL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030159-00issued2030-11-18
0425-MDR-030158-00issued2030-11-18
0425-MDR-030079-00issued2029-06-13

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