BSN medical GmbH
DE-MF-000005787 · Germany · Hamburg
BSN medical GmbH is registered in the European database on medical devices as a manufacturer, with 1 261 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 215 |
|---|---|
| Class IIb | 46 |
Among these devices, 153 are declared sterile.
Devices declared under this manufacturer
- Actimove®
- Cover-Roll®
- Crepesan®
- Cutimed®
- Elastofix® S
- Fixomull®
- Hypafix®
- Leukomed®
- Leukoplast®
- Leukoplast® leukomed®
- Tensoban®
- Tensofast®
Showing 12 of 1 261 declared devices.
Catalogue references include 72378-04, 72453-00, 73118-01, 73487-16, 75614-37, 75687-55.
European nomenclature codes declared: Y061209, Y06120601, M050201, M030501, M050199, Y060615.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BSN Medical GmbH (DE) · FDA 3017297225 |
| Devices in EUDAMED | 1 261 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 1 261 |
|---|---|
| Found in the U.S. device database | 107 |
| Share | 8.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BSN MEDICAL GMBH |
What it holds in Canada
| Licences on record | 18 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 18 |
| First licensed | 2008-03-19 |
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 GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
50708-60-06-01 | supplemented | 2030-12-14 |