EU → North America Device Access

Oxoid Ltd

GB-MF-000016914 · United Kingdom · Basingstoke, Hampshire

Oxoid Ltd is registered in the European database on medical devices as a manufacturer, with 526 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Authorised representative in the Union: Thermo Fisher Diagnostics B.V..

Devices declared under this manufacturer

Showing 12 of 526 declared devices.

Catalogue references include BO0336B, CM0001B, CM0053B, CM0131W, DR0220M, LR0027A.

European nomenclature codes declared: W0104010101, W0104080502, W0104010104, W0104010405, W0104010306, W0104010999.

United States market access

FDA establishment registerRegistered with FDA
Matched entryOXOID, LTD. (GB) · FDA 8010096
Devices in EUDAMED526
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN526
Found in the U.S. device database252
Share47.9 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryOXOID LIMITED

What it holds in Canada

Licences on record18
Currently active0
Class 2 devices17
Class 3 devices1
First licensed1999-02-22

Licence types: Test Kit (16), Device Family (1), Single Device (1).

Licensed under: ANTIMICROBIAL SUSCEPTIBILITY DISCS, IMAGEN ADENOVIRUS, IMAGEN RESPIRATORY SCREEN, IMAGEN PARAINFLUENZA VIRUS GROUP (TYPES 1,2 AN, PROSPECT ROTAVIRUS, IMAGEN INFLUENZA VIRUS A AND B.

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

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