DMG Chemisch-Pharmazeutische Fabrik GmbH
DE-MF-000006027 · Germany · Hamburg
DMG Chemisch-Pharmazeutische Fabrik GmbH is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 52 |
|---|
Most frequent device types declared: 11TemporaryCement, 13Glassionomere, 2AdhesiveSystems, 4Infiltration, PermanenteCements.
Among these devices, 52 are declared implantable.
Catalogue references include 213200, 213366, 213386, 213388, 220525, 220532.
European nomenclature codes declared: Q01010103, Q01010106, Q0101010203, Q0199, Q01010402, Q01010104.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH (DE) · FDA 8044164 |
| Devices in EUDAMED | 52 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH |
What it holds in Canada
| Licences on record | 22 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 18 |
| First licensed | 2004-11-22 |
Licence types: System (9), Device Group Family (5), Single Device (4), Device Family (3).
Licensed under: TEMPO CEM, LUXATEMP AUTOMIX, LUXAGLAZE, LUXAFLOW, LUXA CORE, LUXABOND.
North American profile: Both markets. DMG Chemisch-Pharmazeutische Fabrik GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0302GB448240604 | issued | 2027-12-21 |