EU → US Device Access

Mectronic Medicale srl

IT-MF-000040989 · Italy · Grassobbio (BG)

Mectronic Medicale srl is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb19
Class IIa1

Most frequent device types declared: IXYON XP, DOCTOR TECAR SMART, ILUX LF, DOCTOR TECAR PLUS, iLux LF Y10.

Among these devices, 19 are declared active.

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 entryMECTRONIC MEDICALE S.R.L. (IT) · FDA 3015283772
Devices in EUDAMED20
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
183/MDRissued2029-09-16

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