EU → North America Device Access

NIPI-M AD

BG-MF-000033684 · Bulgaria · Stara Zagora

NIPI-M AD is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: VEG1-000BG, VEG180-000BG, VG1-000BG, VG180-000BG.

Among these devices, 4 are declared active.

Devices declared under this manufacturer

Catalogue references include 300002/IZ, 300005/IZ, 300008/IZ, 300009, 300011.

European nomenclature codes declared: V080699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationBulgaria

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

Device-level evidence

Devices with a numeric GTIN5
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. NIPI-M AD was not found in either the U.S. or the Canadian register.

Other manufacturers in Bulgaria

All Bulgaria manufacturers →