EU → North America Device Access

Cipher Surgical Limited.

GB-MF-000008065 · United Kingdom · Coventry

Cipher Surgical Limited. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Most frequent device types declared: CU3DI3.

Among these devices, 6 are declared sterile, 7 active.

Authorised representative in the Union: Advena Limited.

Catalogue references include CS-10-00-300, CS-10-00-315, CS-10-00-330, CS-10-30-300, CS-10-30-315, CS-10-30-330.

European nomenclature codes declared: Z12029015, Z12019007.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCIPHER SURGICAL LTD (GB) · FDA 3013348547
Devices in EUDAMED7
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database7
Share100.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCIPHER SURGICAL LIMITED

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2016-04-21

Licence types: System (1).

Licensed under: OPCLEAR.

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

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