EU → North America Device Access

Planer Limited

GB-MF-000002773 · United Kingdom · Sunbury-on-Thames

Planer Limited is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa15

Most frequent device types declared: BT37, CT37stax, Kryo560.

Among these devices, 15 are declared active.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 15 declared devices.

Catalogue references include GDBT37-01-ORIGIO, GDBT37-02-CS, GDBT37-WW-ORIGIO, GDCT37-M, GDCT37-M-3, Kryo360-3.3.

European nomenclature codes declared: U080299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPLANER Limited (GB) · FDA 3002465911
Devices in EUDAMED15
Country of registrationUnited Kingdom

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. Planer Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →