EU → North America Device Access

Sopharma AD

BG-MF-000019983 · Bulgaria · Sofia

Sopharma AD is registered in the European database on medical devices as a manufacturer, with 195 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa195

Most frequent device types declared: Lotion for lice infection prevention, Shampoo against lice and nits.

Among these devices, 46 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 195 declared devices.

Catalogue references include 32001000-0066, 32001000-0078, 32001000-0114, 32001000-0115, 32002000-0027, 32003000-0011.

European nomenclature codes declared: M050101, M030405, M03040299, M030101, M04010199, M04010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED195
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 GTIN195
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. Sopharma AD was not found in either the U.S. or the Canadian register.

Other manufacturers in Bulgaria

All Bulgaria manufacturers →