EU → North America Device Access

BSN medical SAS

FR-MF-000000598 · France · Vibraye

BSN medical SAS is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa28

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include 02702-00, 47190-00, 71105-00, 71990-02, 72050-60, 72050-61.

European nomenclature codes declared: M0304010301, M0304010302, M03050201, M050101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBSN Medical GmbH (DE) · FDA 3017297225
Devices in EUDAMED28
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN28
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBSN MEDICAL GMBH

What it holds in Canada

Licences on record18
Currently active0
Class 2 devices18
First licensed2008-03-19

Licence types: Device Family (12), Single Device (5), Device Group Family (1).

Licensed under: CUTICELL CLASSIC PARAFFIN GAUZE DRESSING, CUTIMED CUTICELL OINTMENT DRESSING, CUTIMED SORBACT, CUTIMED GEL, CUTIMED SORBACT GEL, CUTIMED CAVITY, FOAM CAVITY DRESSING.

North American profile: Both markets. BSN medical SAS is registered in both the United States and Canada.

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