EU → North America Device Access

Aesthetic Technology Ltd

GB-MF-000033533 · United Kingdom · Warrington

Aesthetic Technology Ltd is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa10

Most frequent device types declared: 1000007, 1000014, 1000015, 1000018 - Dermalux Tri-Wave MD, 1000023.

Among these devices, 10 are declared active.

Authorised representative in the Union: Emergo Europe B.V..

Devices declared under this manufacturer

Catalogue references include 1000007, 1000014, 1000015, 1000018, 1000032, 1000033.

European nomenclature codes declared: Z12040202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAESTHETIC TECHNOLOGY LTD (GB) · FDA 3017140525
Devices in EUDAMED10
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryAESTHETIC TECHNOLOGY LTD

What it holds in Canada

Licences on record2
Currently active0
Class 2 devices2
First licensed2023-12-04

Licence types: System (2).

Licensed under: DERMALUX FLEX MD, DERMALUX TRI-WAVE MD.

North American profile: Both markets. Aesthetic Technology Ltd is registered in both the United States and Canada.

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