EU → US Device Access

HumanOptics Holding AG

DE-MF-000017892 · Germany · Erlangen

HumanOptics Holding AG is registered in the European database on medical devices as a manufacturer, with 177 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb177

Among these devices, 177 are declared sterile, 177 implantable.

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 entryHUMANOPTICS HOLDING AG (DE) · FDA 3010531293
Devices in EUDAMED177
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
44912221836supplemented2030-06-12
44911221836supplemented2030-06-12

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