EU → US Device Access

Active Medical Xcellence GmbH

DE-MF-000049306 · Germany · Jena

Active Medical Xcellence GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa5

Most frequent device types declared: activeCut.

Among these devices, 5 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 entryACTIVE MEDICAL, INC. (US) · FDA 2529647
Devices in EUDAMED5
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.

Notified body certificates

CertificateStatusExpiry
111178U2supplemented2030-12-15

Other manufacturers in Germany

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