EU → North America Device Access

Actegy Limited

GB-MF-000032543 · United Kingdom · Bracknell

Actegy Limited is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa12

Most frequent device types declared: 12120-5575AQ-FR, 2837AB-FR-BEN, 3481AJ, 5572AQ-DE, 5572AQ-FR-BEN.

Among these devices, 12 are declared active.

Authorised representative in the Union: MDSS GmbH.

Devices declared under this manufacturer

Catalogue references include 12120-5575AQ-FR, 2837AB, 3481AJ, 5572AQ, 5573AQ, 5574AQ.

European nomenclature codes declared: Z120622, R050280.

United States market access

FDA establishment registerRegistered with FDA
Matched entryACTEGY LTD. (GB) · FDA 3010078417
Devices in EUDAMED12
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN11
Found in the U.S. device database1
Share9.1 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryACTEGY LIMITED

North American profile: Both markets. Actegy Limited is registered in both the United States and Canada.

Other manufacturers in United Kingdom

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