EU → North America Device Access

Alerta Medical Ltd

GB-MF-000013708 · United Kingdom · Irvine

Alerta Medical Ltd is registered in the European database on medical devices as a manufacturer, with 302 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa302

Among these devices, 6 are declared active.

Authorised representative in the Union: CS Life Sciences Europe Ltd.

Devices declared under this manufacturer

Showing 12 of 302 declared devices.

Catalogue references include ALT-9450, ALT-BE008, ALT-BE009/B, ALT-SAF-L, BAM-D, DAM-RUST-MED01.

European nomenclature codes declared: Y215199, V08068099, Y090699, Y091203, Y120606, V080302.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAlerta Medical Ltd (GB) · FDA 3013548496
Devices in EUDAMED302
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN302
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: United States only. Alerta Medical Ltd is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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