EU → North America Device Access

Covision Medical Technologies Ltd.

GB-MF-000025081 · United Kingdom · Nottinghamshire

Covision Medical Technologies Ltd. is registered in the European database on medical devices as a manufacturer, with 1 501 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I1 375
Class IIa125
Class IIb1

Most frequent device types declared: ANCALE CS TIBIAL INSERT HIGHLY CROSSLINK (XL) SIZE 6-25 MM, ANCALE PS TIBIAL INSERT SIZE 4-9 MM, REFLECTO FEMORAL COMPONENT CEMENTED RIGHT SIZE 3, REFLECTO TIBIAL INSERT SIZE 1 X 18 MM, RIGID REAMER CASE.

Among these devices, 1 373 are declared sterile, 1 375 implantable, 125 reusable, 2 with a measuring function.

Authorised representative in the Union: Covision Medical Technologies (Ireland) Limited.

Devices declared under this manufacturer

Showing 12 of 1 501 declared devices.

Catalogue references include 01.3507N, 01.4706N, 01.8602N, 01.9726, 01.9740, 02.0421.

European nomenclature codes declared: P090903020202, P090903020201, L091199, P090804010201, P090905020202, P09098001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 501
Country of registrationUnited Kingdom

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN1 501
Found in the U.S. device database0
Share0.0 %

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: Neither register. Covision Medical Technologies Ltd. was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →