EU → North America Device Access

Crab Sinergy Srl

IT-MF-000008825 · Italy · COSTA VOLPINO

Crab Sinergy Srl is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb5
Class IIa6

Most frequent device types declared: VAGINAL GELS.

Devices declared under this manufacturer

Catalogue references include AR1354, AR1358, BNIS001, PLF G 001, SFN10, VHG 001.

European nomenclature codes declared: U0803, Q030199, V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. Crab Sinergy Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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