EU → North America Device Access

Glaxo Operations UK Ltd

GB-MF-000029111 · United Kingdom · Barnard Castle, County Durham

Glaxo Operations UK Ltd is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Authorised representative in the Union: GlaxoSmithKline Trading Services Limited.

Devices declared under this manufacturer

Catalogue references include 10000000048312, 1303005, 1306323, 62000000083455, 62000000086657.

European nomenclature codes declared: A99.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. Glaxo Operations UK Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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