EU → US Device Access

Technolas Perfect Vision GmbH

DE-MF-000007094 · Germany · Munich

Technolas Perfect Vision GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb13
Class IIa4

Among these devices, 2 are declared sterile, 14 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 registerRegistered with FDA
Matched entryTECHNOLAS PERFECT VISION GMBH (DE) · FDA 3007606649
Devices in EUDAMED17
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
HZ 1061119-1supplemented2028-07-11

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