EU → North America Device Access

Coroventis Research AB

SE-MF-000002888 · Sweden · Uppsala

Coroventis Research AB is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Most frequent device types declared: 12000WW, 12004.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include 12000-30, 12000-31, 12000WW, 12001, 12004.

European nomenclature codes declared: Z12050782.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCOROVENTIS RESEARCH AB (SE) · FDA 3017845286
Devices in EUDAMED5
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database3
Share60.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCOROVENTIS RESEARCH AB

What it holds in Canada

Licences on record1
Currently active0
Class 3 devices1
First licensed2023-03-01

Licence types: System (1).

Licensed under: COROFLOW CARDIOVASCULAR SYSTEM.

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

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