EU → North America Device Access

PRODCONFARM SRL

RO-MF-000017975 · Romania · PITESTI

PRODCONFARM SRL is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: FESI TIFON 10m/15cm / GAUZE BANDAGES 10m / 15cm, STERILE GAUIZE COMPRESSES CUTTED 10cm/10cmx10ply, STERILE GAUZE COMPRESSES 10 cm / 20 cm, STERILE GAUZE COMPRESSES 10cm/8cmx50ply, STERILE GAUZE COMPRESSES 20 cm / 20 cm.

Among these devices, 14 are declared sterile.

Catalogue references include PROD CS 02, PROD CS 8, PRODCN014040, PRODCS1, PRODCS42, PRODF051010.

European nomenclature codes declared: M0201050101, M030101, M0201020102, M0201020101, M0201010101, M0201010102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
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 GTIN14
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. PRODCONFARM SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Romania

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