Data / Medical devices / Germany / MedSkin Solutions Dr. Suwelack AG
MedSkin Solutions Dr. Suwelack AG: FDA-registered device maker in BILLERBECK North Rhine-Westphalia, Germany, 3 510(k) clearances
MedSkin Solutions Dr. Suwelack AG is registered with the FDA (registration 3002636527) in BILLERBECK North Rhine-Westphalia, Germany. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002636527
- Address
- Josef-Suwelack-Strasse 2, BILLERBECK North Rhine-Westphalia, Germany, 48727
- Owner or operator
- MedSkin Solutions Dr. Suwelack AG (9083271)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- July 26, 2006
- Registered through
- 2026
- Brand names listed
- MatriDerm, MatriDerm pluS+ Bi-Layer, Puracol Plus Ag Collagen Wound Dressing, Puracol-Puracol Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Contract manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Contract manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 19, 2025 | K250864 | MatriDerm pluS+ Bi-Layer | KGN | Substantially Equivalent | Medskin Solutions Dr. Suwelack AG | accessdata.fda.gov |
| January 7, 2021 | K201577 | MatriDerm | KGN | Substantially Equivalent | Medskin Solutions Dr. Suwelack AG | accessdata.fda.gov |
| August 26, 2009 | K091338 | COLLASORB COLLAGEN WOUND DRESSING | KGN | Substantially Equivalent | Hartmann-Conco, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Dressing, Wound, Drug
Updated December 19, 2025. 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.