EU → US Device Access

Lode B.V.

NL-MF-000001493 · Netherlands · Groningen

Lode B.V. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa9

Among these devices, 9 are declared active, 9 with a measuring function.

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 registerRegistered with FDA
Matched entryLODE B.V. (NL) · FDA 8030476
Devices in EUDAMED9
Country of registrationNetherlands

Notified body certificates

CertificateStatusExpiry
2246826CE01supplemented2027-01-01

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