EU → US Device Access

METASYS Medizintechnik GmbH

AT-MF-000014438 · Austria · Rum

METASYS Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 144 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa144

Most frequent device types declared: Dental suction system pump, Combination water purification system, Dental amalgam waste separator, centrifugation, Disinfectant spray, Dental suction system fluid-separation unit.

Among these devices, 110 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 registerNot found in the FDA register
Devices in EUDAMED144
Country of registrationAustria
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
44911220982restricted2029-08-08

Other manufacturers in Austria

All Austria manufacturers →