EU → North America Device Access

Endomagnetics Ltd.

GB-MF-000007233 · United Kingdom · Cambridge

Endomagnetics Ltd. is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa18

Among these devices, 18 are declared reusable, 18 active.

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

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include R-SMB02, R-SMP02, SMA, SMA03, SMC02, SMP02.

European nomenclature codes declared: A019012.

United States market access

FDA establishment registerRegistered with FDA
Matched entryENDOMAGNETICS LTD (GB) · FDA 3012644426
Devices in EUDAMED18
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN18
Found in the U.S. device database10
Share55.6 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryENDOMAGNETICS LTD.

What it holds in Canada

Licences on record4
Currently active0
Class 3 devices4
First licensed2017-04-27

Licence types: System (2), Single Device (1), Device Family (1).

Licensed under: MAGSEED NEEDLE WITH MAGNETIC MARKER SYSTEM, SENTIMAG SYSTEM, SENTIMAG SYSTEM, MAGSEED PRO MAGNETIC MARKER SYSTEM.

North American profile: Both markets. Endomagnetics Ltd. is registered in both the United States and Canada.

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