Medskin Solutions Dr. Suwelack AG
DE-MF-000007747 · Germany · Billerbeck
Medskin Solutions Dr. Suwelack AG is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 49 |
|---|
Most frequent device types declared: MatriDerm, ProHeal.
Among these devices, 49 are declared sterile, 37 implantable.
Devices declared under this manufacturer
- Cutimed Epiona
- MatriDerm
- MatriDerm Dermal Matrix
- MatriDerm Fenestrated Dermal Matrix
- ProHeal
Showing 12 of 49 declared devices.
Catalogue references include 83032-001, 83400-200, 83411-200, 83421-200, 83441-200, 83461-200.
European nomenclature codes declared: P900404, M04041002, M04041001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MedSkin Solutions Dr. Suwelack AG (DE) · FDA 3002636527 |
| Devices in EUDAMED | 49 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 49 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDSKIN SOLUTIONS DR. SUWELACK AG |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 4 devices | 1 |
| First licensed | 2018-02-28 |
Licence types: Device Family (1).
Licensed under: MATRIDERM DERMAL MATRIX.
North American profile: Both markets. Medskin Solutions Dr. Suwelack AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1354GB448260706 | supplemented | 2029-10-19 |
11833GB450260706 | issued | 2031-07-05 |
11832GB450260721 | issued | 2031-07-20 |
11830GB450260122 | issued | 2031-01-21 |