Data / Medical devices / Germany / BSN Medical GmbH
BSN Medical GmbH: FDA-registered device maker in Hamburg, Germany, 6 510(k) clearances
BSN Medical GmbH is registered with the FDA (registration 3017297225) in Hamburg, Germany. It lists 26 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017297225
- Address
- Schutzenstrasse 1-3, Hamburg, Germany, 22761
- Owner or operator
- BSN medical GmbH (9047426)
- Roles
- Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer
- First device listed
- December 27, 1983
- Registered through
- 2026
- Brand names listed
- , Jobst Comprifore #2, ACTIMOVE KIDS ELBOW SUPPORT, ADJUSTABLE, ACTIMOVE KIDS WRIST STABILIZER, REMOVABLE METAL STAY, LEFT OR RIGHT, ACTIMOVE POST-OP ROM KNEE BRACE, ACTIMOVE PROFESSIONAL LINE MANUS, WRIST STABILIZER, Actimove Alufoam, Actimove Arthritis Care Ankle Support, Actimove Arthritis Care Arthritis Gloves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Abdominal | KTD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Rib Fracture, Soft | IPX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shoe, Cast | IPG | 1 | Exporter to the US | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sling, Arm, Overhead Supported | ILE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Splint, Clavicle | IQJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Venous Ulcer Kit | PYK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 21, 2017 | K171225 | Sorbact Wound Dressing-Ribbon Gauze | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
| 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 |
| January 24, 2011 | K100591 | SORBACT | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
| August 26, 2009 | K091338 | COLLASORB COLLAGEN WOUND DRESSING | KGN | Substantially Equivalent | Hartmann-Conco, Inc. | 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 Sling, Arm
- All makers of Sling, Arm, Overhead Supported
- All makers of Pad, Eye
- All makers of Orthosis, Rib Fracture, Soft
- All makers of Tape And Bandage, Adhesive
- All makers of Joint, Ankle, External Brace
Updated August 21, 2017. 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.