EU → US Device Access

Quantum Surgical SAS

FR-MF-000000600 · France · montpellier

Quantum Surgical SAS is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa15

Most frequent device types declared: 30-0001, 02-0026, 30-0004, 02-0027.

Among these devices, 7 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 registerRegistered with FDA
Matched entryQUANTUM SURGICAL SAS (FR) · FDA 3023140882
Devices in EUDAMED15
Country of registrationFrance

Notified body certificates

CertificateStatusExpiry
HZ 1551912-1reissued2031-08-30

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