EU → North America Device Access

FIRST IMPEX srl

RO-MF-000041608 · Romania · CHISCANI

FIRST IMPEX srl 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: MA1, MT, MTS1, PARAVAN MEDICAL CADRU METALIC, colector pansamente cu doua boluri.

Devices declared under this manufacturer

Catalogue references include 4001, 4005, 4006, 4008, 4011, 4016.

European nomenclature codes declared: V0499, V080603, V9099, V08020101, V080602.

United States market access

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

⚠️ 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. FIRST IMPEX srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Romania

All Romania manufacturers →