EU → North America Device Access

PROMT MARKET KFT.

HU-MF-000002966 · Hungary · Budapest

PROMT MARKET KFT. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa12

Most frequent device types declared: ISZ3, ITB, Kramersin40, NAPIGY, Promtmarket 1,5.

Among these devices, 1 are declared reusable, 1 active.

Devices declared under this manufacturer

Catalogue references include HETIGYA, ITB, Krammesrin 60 cm, LLT, NAPIGY, VKF.

European nomenclature codes declared: T030599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
Country of registrationHungary

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

Device-level evidence

Devices with a numeric GTIN12
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. PROMT MARKET KFT. was not found in either the U.S. or the Canadian register.

Other manufacturers in Hungary

All Hungary manufacturers →