EU → US Device Access

NVT GmbH

DE-MF-000005426 · Germany · Hechingen

NVT GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I6

Most frequent device types declared: ALLEGRA THV, IMPERIA, ALLEGRA Delivery System TF.

Among these devices, 6 are declared sterile, 3 implantable.

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 EUDAMED6
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
51380-61-D0-00issued2030-06-19
51380-61-C0-00issued2027-07-28
51380-61-B0-01issued2027-07-28
51380-60-04-00issued2030-09-20

Other manufacturers in Germany

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