EU → North America Device Access

Theraplay Ltd

UK-MF-000053722 · United Kingdom · East Kilbride

Theraplay Ltd is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Most frequent device types declared: Adaptive Tricycle - Non Motorised.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Catalogue references include TI1, TR1, TRC2, TS1, TT1, TX1.

European nomenclature codes declared: Y121806.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTheraplay Ltd (GB) · FDA 3000286776
Devices in EUDAMED7
Country of registrationUnited Kingdom

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: United States only. Theraplay Ltd is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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