EU → North America 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 Delivery System TF, ALLEGRA THV, IMPERIA.

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

Devices declared under this manufacturer

Catalogue references include DSL-AO18G1RE1150, DSL-AO18G2115M, DSL-AO18G2115S, THV-AO0023G1RE, THV-AO0027G1RE, THV-AO0031G1RE.

European nomenclature codes declared: P07038002, P070301030201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN6
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. NVT GmbH was not found in either the U.S. or the Canadian register.

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

All Germany manufacturers →