EU → North America Device Access

Zethon Ltd

GB-MF-000014309 · United Kingdom · Aston Clinton

Zethon Ltd is registered in the European database on medical devices as a manufacturer, with 349 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa346
Class I3

Most frequent device types declared: A-C10, C07-01551, C07-02061E, C07-06051, C07-07061.

Among these devices, 300 are declared sterile, 17 active.

Authorised representative in the Union: De Soutter Medical Limited.

Catalogue references include A-C10, C07-01551, C07-02061E, C07-07531, C10-05031, C12-03031S.

European nomenclature codes declared: Z12100985, Z12100902, Z12100980, A03040299, Z12139080, Z12139005.

United States market access

FDA establishment registerRegistered with FDA
Matched entryZETHON LTD (GB) · FDA 3016172274
Devices in EUDAMED349
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN349
Found in the U.S. device database281
Share80.5 %

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. Zethon Ltd is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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