EU → North America Device Access

Neoss AB

SE-MF-000022321 · Sweden · Göteborg

Neoss AB is registered in the European database on medical devices as a manufacturer, with 209 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa209

Among these devices, 118 are declared sterile, 129 reusable.

Devices declared under this manufacturer

Showing 12 of 209 declared devices.

Catalogue references include 41140, 41152, 41162, 41184, 41206, 51211.

European nomenclature codes declared: P01020180, P01020101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNEOSS AB (SE) · FDA 3017399129
Devices in EUDAMED209
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN209
Found in the U.S. device database141
Share67.5 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryNEOSS LTD

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

Other manufacturers in Sweden

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