EU → North America Device Access

Betamed Srl

IT-MF-000034707 · Italy · Roma RM

Betamed Srl is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa27

Most frequent device types declared: DILATATORI CERVICALI STERILI, KIT PROCEDURALE.

Among these devices, 27 are declared sterile.

Catalogue references include 05BMANC.00/RM6, 05BMANG.01/SSF, 05BMCES.00/R6, 05BMEND.00/RM6, 05BMGIN.AR/RM6, 05BMPAS.00/R6.

European nomenclature codes declared: T0202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED27
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN27
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. Betamed Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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