DETAX GmbH & Co. KG
DE-MF-000005995 · Germany · Ettlingen
DETAX GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 315 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 315 |
|---|
Among these devices, 1 are declared implantable.
Devices declared under this manufacturer
- Detaseal hydroflow mono 4x50ml
- Detaseal hydroflow xlite reg. 4x50 ml
- Exact Putty Fast
- MOLLOPLAST-B Großpackung
- Mischkanülen braun 1:1 25 St.
- Mischkanülen mini-mix grün 1:1 25 St. Audio
- OTO Mischkanülen A2 blau lang 25 St.
- Silaplast FUTUR Standardpack. 900 ml
- Ultraprint-Dental IBT UV 1.000 g
- addition mini Junior Refill
- addition protect 8 x 50 ml
- addition ultra Kartuschenpck.
Showing 12 of 315 declared devices.
Catalogue references include 02082, 02450, 02761, 02768, 02989, 03440.
European nomenclature codes declared: Q030499, Q01020104, Q0102050101, Q010280, Q010299, Q010499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DETAX GMBH (DE) · FDA 9680954 |
| Devices in EUDAMED | 315 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DETAX GMBH |
What it holds in Canada
| Licences on record | 16 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 3 devices | 1 |
| First licensed | 2006-06-26 |
Licence types: Device Family (10), System (5), Single Device (1).
Licensed under: TEMPOFIT, MOLLOPLAST B, MOLLOSIL PLUS, MOLLOSIL (RELINING MATERIAL), IMPLANTLINK SEMI, FREEFORM.
North American profile: Both markets. DETAX GmbH & Co. KG is registered in both the United States and Canada.