EU → US Device Access

BRM Extremities S.r.l.

IT-MF-000016087 · Italy · Milano

BRM Extremities S.r.l. is registered in the European database on medical devices as a manufacturer, with 936 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb688
Class IIa238
Class I10

Among these devices, 368 are declared sterile, 698 implantable, 84 reusable.

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 registerSimilar name found — unverified
Matched entryBRM EXTREMITIES SRL (IT) · FDA 3016669046
Devices in EUDAMED936
Country of registrationItaly
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
087-00-00-MDRissued2030-12-02
060-00-00-MDRwithdrawn2029-09-19
059-00-02-MDRsupplemented2029-09-19

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