Dermaroller GmbH
DE-MF-000005021 · Germany · Wolfenbüttel
Dermaroller GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 13 |
|---|
Most frequent device types declared: MC402, MC405, MC410, MC415, MC420, MC425, MC902, MC905, MC910, MC915, .
Among these devices, 13 are declared sterile.
Devices declared under this manufacturer
- Dermaroller
Showing 12 of 13 declared devices.
Catalogue references include MC402, MC410, MC415, MC425, MC905, MC910.
European nomenclature codes declared: V901602.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Dermaroller GmbH (DE) · FDA 3007361698 |
| Devices in EUDAMED | 13 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DERMAROLLER GMBH |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2015-12-07 |
Licence types: System (2), Device Family (1).
Licensed under: EDERMASTAMP, DERMAROLLER MC, XCELLARISPRO TWIST MICRONEEDLING-SYSTEM.
North American profile: Both markets. Dermaroller GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
6191GB449250723 | supplemented | 2028-09-02 |