EU → US 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 IIb7
Class IIa3

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

Among these devices, 10 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

Other manufacturers in Italy

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