EU → North America Device Access

ITP Innovative Tomography Products GmbH

DE-MF-000008634 · Germany · Bochum

ITP Innovative Tomography Products GmbH is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa50

Most frequent device types declared: BIM18/10, Biopsy Needle, Coaxial Interventional Needle.

Among these devices, 50 are declared sterile.

Catalogue references include BIM18/10, BIM18/20i, KIM13/04T, KIM15/09T, KIM16/09T, KIR17/30.

European nomenclature codes declared: A01020102, A0102010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED50
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 GTIN50
Found in the U.S. device database31
Share62.0 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. ITP Innovative Tomography Products GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →