EU → North America Device Access

Creo Medical

GB-MF-000019076 · United Kingdom · Chepstow

Creo Medical is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb15
Class IIa7

Most frequent device types declared: 7-EMR-050.

Among these devices, 12 are declared sterile, 15 active.

Authorised representative in the Union: Creo Medical, S.L.U..

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 7-AB1-002, 7-EMR-050, 7-NP1-100, 7-RS2-210, PRD-IFC-001, PRD-PC1-001.

European nomenclature codes declared: K0299, K02010203, Z12010902, K0180, Z12010980, L99.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCREO MEDICAL LTD (GB) · FDA 3014925413
Devices in EUDAMED22
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN22
Found in the U.S. device database6
Share27.3 %

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. Creo Medical is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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