EU → North America Device Access

Better2Know

UK-MF-000044952 · United Kingdom · Kirkby Lonsdale

Better2Know is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: Specimen Receptacles.

Authorised representative in the Union: Patient Guard Europe UG.

Devices declared under this manufacturer

Catalogue references include BHT0026, BHT0027, BHTK0021, BHTK0022, BHTK0023, BHTK0024.

European nomenclature codes declared: W050101010102, W05010202, W0503010280.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. Better2Know was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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