EU → North America Device Access

Airglove Medical Ltd

UK-MF-000048008 · United Kingdom · East Kilbride

Airglove Medical Ltd is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Among these devices, 6 are declared active.

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

Devices declared under this manufacturer

Catalogue references include GB002, GL 5013, GL 5014, GL 5015, GL 5016, GL501.

European nomenclature codes declared: Z12019008.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAIRGLOVE MEDICAL LIMITED (GB) · FDA 3042886188
Devices in EUDAMED6
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN6
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. Airglove 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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