EU → North America Device Access

Alesi Surgical

GB-MF-000003881 · United Kingdom · Cardiff

Alesi Surgical is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb5

Most frequent device types declared: DAD-001-003, DAD-003-013, DPD-006-001, DPD-006-201, DPD-007-001.

Among these devices, 4 are declared sterile, 5 active.

Authorised representative in the Union: Advena Limited.

Catalogue references include DAD-001-003, DAD-003-013, DPD-006-001, DPD-006-201, DPD-007-001.

European nomenclature codes declared: K02010107.

United States market access

FDA establishment registerRegistered with FDA
Matched entryALESI SURGICAL LTD (GB) · FDA 3012582478
Devices in EUDAMED5
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database5
Share100.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryALESI SURGICAL LIMITED

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

Other manufacturers in United Kingdom

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