EU → US Device Access

Meditech Sachsen GmbH

DE-MF-000026657 · Germany · Pulsnitz

Meditech Sachsen GmbH is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa16

Most frequent device types declared: VARIO Hubsäulentherapieliege.

Among these devices, 11 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 registerSimilar name found — unverified
Matched entryMEDITECH KFT. (HU) · FDA 3003764019
Devices in EUDAMED16
Country of registrationGermany
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Germany

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