EU → North America Device Access

CHARCO NEUROTECH LTD

GB-MF-000018851 · United Kingdom · Cambridge

CHARCO NEUROTECH LTD 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 IIa11

Most frequent device types declared: CUE1, CUE1+ (Deep Ocean), CUE1+ (Deep Ocean) System.

Among these devices, 7 are declared active.

Authorised representative in the Union: European Healthcare & Device Solutions Ltd..

Devices declared under this manufacturer

Catalogue references include CN000100, CN000100_B, CN000100_S, CN000110, CN000120, CN000210.

European nomenclature codes declared: Z12101106.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationUnited Kingdom

⚠️ 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. CHARCO NEUROTECH LTD was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →