EU → North America Device Access

Sterimedix Ltd

GB-MF-000011604 · United Kingdom · Redditch

Sterimedix Ltd is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa29

Most frequent device types declared: 4474-02, 4477-03, 4477-03P, 4477NS-02/Y, 4486-03.

Among these devices, 28 are declared sterile.

Authorised representative in the Union: Bausch & Lomb GmbH.

Catalogue references include 4474-02, 4477-02, 4477-02/Y, 4477-03P, 4486-03, 4504-02.

European nomenclature codes declared: Q021101.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySTERIMEDIX LTD. (GB) · FDA 1000614268
Devices in EUDAMED29
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN9
Found in the U.S. device database5
Share55.6 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entrySTERIMEDIX LTD.

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

Other manufacturers in United Kingdom

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