EU → North America Device Access

SC MEBRA SRL

RO-MF-000017978 · Romania · Brasov

SC MEBRA SRL is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: 1252, 206.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 50000012, 61782055, 61783106, 61783206, 61791005, 61792005.

European nomenclature codes declared: M030101, Z11049085, M040199, M050202, V0799.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
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 GTIN22
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. SC MEBRA SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Romania

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