EU → North America Device Access

Firstkind Limited

GB-MF-000010541 · United Kingdom · High Wycombe

Firstkind Limited is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa17

Most frequent device types declared: A-2, K-1, T-2, T-3, W-3.

Among these devices, 11 are declared active.

Authorised representative in the Union: Emergo Europe B.V..

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include DT2EN01, MA2RW10, MK1RW02, SK1RW02, ST2RW02, T3FE02.

European nomenclature codes declared: N0199, M9099, V0499.

United States market access

FDA establishment registerRegistered with FDA
Matched entryFIRSTKIND LTD (GB) · FDA 3011197543
Devices in EUDAMED17
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN17
Found in the U.S. device database3
Share17.6 %

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

Other manufacturers in United Kingdom

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