EU → US Device Access

Geratherm Medical GERMANY GmbH

DE-MF-000007307 · Germany · Geratal

Geratherm Medical GERMANY GmbH is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa23
other3

Most frequent device types declared: GT-1000, GT-2000, GT-1215, KP-6130, GT-195-1.

Among these devices, 1 are declared sterile, 14 active, 22 with a measuring function.

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 EUDAMED26
Country of registrationGermany
⚠️ 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
HZ 2616312-1issued2029-11-10

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