Data / Medical devices / Germany / BSN Medical GMBH
BSN Medical GMBH: FDA-registered device maker in Hamburg, Germany, 3 510(k) clearances
BSN Medical GMBH is registered with the FDA (registration 9710608) in Hamburg, Germany. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 1, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710608
- FEI number
- 3003441980
- Address
- Heykenaukamp 10, Hamburg, Germany, D-21147
- Owner or operator
- BSN medical GmbH (9047426)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 27, 1999
- Registered through
- 2026
- Brand names listed
- Coach, Cover-Roll stretch, Cuticell Contact, Cutimed Cavity, Cutimed Cuticell, Cutimed Hydro B, Cutimed Hydro L, Cutimed Siltec and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2016 | K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
| January 26, 2015 | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) | FRO | Substantially Equivalent | Bsn Medical GmbH | accessdata.fda.gov |
| April 19, 2007 | K063059 | SORBACT WOUND DRESSING | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Occlusive
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrophilic
- All makers of Tape And Bandage, Adhesive
Updated July 1, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.