EU → North America Device Access

Bluetree Medical Limited

GB-MF-000017859 · United Kingdom · Rotherham

Bluetree Medical Limited is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Authorised representative in the Union: Patient Guard Europe UG.

Devices declared under this manufacturer

Catalogue references include BS11RT, OB11, OB11C, OB11R, OB11RC, OB11T.

European nomenclature codes declared: T020604, T020699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. Bluetree Medical Limited was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →